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  • 1
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    CO-STAR: Surgical conversion feasibility trial of sintilimab (PD-1 inhibitor) combined with Nab-PTX, S-1 and apatinib for the first-line treatment of stage IV gastric cancer (GC).
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e16041-e16041
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e16041-e16041
    Abstract: e16041 Background: Chemotherapy and PD-1 inhibitor have shown significant clinical benefits in first-line treatment of GC, overall survival was still dismal. The surgical intervention with curative or life prolonging intention was evaluated as feasible for stage IV GC from clinical trials and retrospective cohorts. Our previous study of cytotoxic chemotherapy (S-1 & PTX) in combination with multi-targets anti-angiogenic TKIs illustrated increased response and R0 resection rate. Given the enhanced response from chemo, PD-1 and TKIs regimens, this trial was designed to assess the feasibility of surgical conversion from this combination in stage IV GC. Methods: This is a prospective, single-arm, single-center, phase II trial. Eligible criteria were treatment naïve, histopathologically confirmed stage IV (AJCC8 th ) and ECOG PS 0-1 GC adenocarcinoma. Pts were given with sintilimab (200mg, iv, d1) combined with Nab-PTX (w/o peritoneal spread: 260 mg/m 2 , iv, d1; w/ peritoneal spread: 180 mg/m 2 , iv, d1 and 80 mg/m 2 , ip, d1), S-1 (60mg, po, bid, d1-14), and apatinib (250mg, po, qd) every 3 wks. Tumor response was assessed every 2-4 cycles by radiologic imaging and MDT was employed to determine surgical feasibility. Safety run-in was employed in the first 3+3 pts by DLTs to determine the tolerability. The primary endpoint was ORR and R0 surgical conversion rate. Results: 42 pts were enrolled up to 2/2021. The median follow-up was 3.5m (range 0.7-11.3). The median age was 56 yrs (range 31-72), male was 47.6%, and PS 1 was 31.0%. The metastatic factors were characterized as No.16 lymph nodes 54.8% (23), liver 23.8% (10), peritoneum 40.5% (17), Krukenberg 2.4% (1), and extensive metastases (≥2 organs) 42.9% (18). No DLT occurred in initial 6 pts. Of 36 evaluable pts, ORR was 61.1% and DCR was 97.2%. Surgical conversion was currently identified in 18 pts with 94.4% (17) R0 resection, and the R0 surgical conversion rate was 47.2% (17/36). Median treatment cycle in converted pts was 4. 22.2% (4/18) pts achieved pathological complete response (TRG 0), and 27.8% (5/18) pts had major response (TRG 0-1). The most common AEs were grade 1-2, and 1 SAE of hemorrhage grade 4 occurred. No increase of anastomotic leakage, hemorrhage, and abdominal infection, and no surgery caused death and complication caused second operation occurred. The median postoperative length of stay was 9.5d (range 6-16). Conclusions: These preliminary results showed favorable tumor response and acceptable tolerability for potential surgical resection. Sintilimab, doublet chemotherapy, and apatinib might offer an opportunity of cure for stage IV gastric cancer. Trial ID: NCT04267549. Clinical trial information: NCT04267549. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e16041
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 2
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    PERSIST: A multicenter, randomized phase II trial of perioperative oxaliplatin and S-1 (SOX) with or without sintilimab in resectable locally advanced gastric/gastroesophageal junction cancer (GC/GEJC).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 4_suppl ( 2023-02-01), p. 364-364
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 4_suppl ( 2023-02-01), p. 364-364
    Abstract: 364 Background: RESOLVE study shows clinically meaningful improvement in perioperative SOX in patients with locally advanced GC/GEJC undergoing D2 gastrectomy. Addition of PD-1 inhibitor to chemotherapy shows significant clinical benefit in first-line treatment of advanced GC/GEJC. This trial was designed to compare the perioperative sintilimab combined with SOX versus perioperative SOX in patients with resectable locally advanced GC/GEJC. Methods: PERSIST is a multicenter, prospective, open-label, randomized-controlled phase II study. Patients with histologically or cytologically confirmed GC/GEJC, clinical stage II-III, no previous systemic treatment, ECOG performance status (PS) of 0 or 1 were eligible for inclusion. Patients will be randomized (1:1) to received either perioperative sintilimab (200 mg d1 Q3W, three cycles preoperatively and up to 1 year postoperatively) in combined with SOX (oxaliplatin 130 mg/m² d1, oral S-1 40–60 mg BID d1-14 Q3W, three cycles preoperatively and five cycles postoperatively) in experimental group or perioperative SOX alone in control group. The primary endpoint was the pCR rate. The secondary endpoints were the MPR rate, down-staging rate, 3-years DFS rate, 5-years OS rate, safety. The study is registered with Clinicaltrials.gov: NCT04982939. Results: As of September 2022, 101 patients were enrolled, with median age 61 years (range 31-75 years), males 85 (84.2%), cT2/3/4/X 2(2.0%)/5(5.0%)/93(92.1%)/1(1.0%), cN0/1/2/3/X 10(10.0%)/42(41.6%)/27(26.7%)/9(8.9%)/13(12.9%), and GC/GEJC 92(91.1%)/9(8.9%). Forty-seven patients (experimental group:26, control group:21) underwent radical resection and all achieved R0 resection. The pCR rates in the experimental group and control group were 26.9% (95%CI 11.6%-47.8%) and 4.8% (95%CI 0.1%-23.8%), respectively. The MPR rates in the experimental group and control group were 69.2% (95%CI 48.2%-85.7%) and 28.6% (95%CI 11.3%-52.2%), respectively. 76.9% (20/26) and 52.4% (11/21) patients achieved down-staging in the experimental group and control group. Three patients developed grade 3–4 surgical complications. Grade 3–4 TRAEs included thrombocytopenia (4.0%), anemia (3.0%), neutropenia (2.0%), allergic reaction (2.0%), pneumonia (1.0%), myocardial infarction (1.0%). The median postoperative hospital stay in the experimental and control group were 10 days (range 7-38 days) and 11 days (range 7-66 days). Conclusions: Compared to SOX chemotherapy alone, sintilimab combined with SOX resulted in an encouraging pCR rate, MPR rate and downstaging rate as perioperative treatment for resectable locally advanced GC/GEJC, and safety was manageable. Clinical trial information: NCT04982939 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.4_suppl.364
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Intraperitoneal Chemotherapy Using Fluorouracil Implants Combined With Radical Resection and Postoperative Adjuvant Chemotherapy for Stage III Gastric Cancer: A Multi-Center, Randomized, Open-Label, Controlled Clinical Study
    Frontiers Media SA ; 2021
    In:  Frontiers in Oncology Vol. 11 ( 2021-7-8)
    Details
    In: Frontiers in Oncology, Frontiers Media SA, Vol. 11 ( 2021-7-8)
    Abstract: Reducing peritoneal recurrence after radical surgery is an important choice to improve the prognosis of patients with advanced gastric cancer. Intraoperative intraperitoneal chemotherapy has the potential to be a promising treatment strategy. In the present study, we conducted a multi-center, randomized, controlled clinical study to evaluate the efficacy and safety of intraoperative intraperitoneal chemotherapy using sustained-release fluorouracil implants plus radical gastrectomy and adjuvant chemotherapy for cTNM stage III gastric cancer. Methods The patients were randomized into intraperitoneal chemotherapy group (sustained-release fluorouracil implants administration after standard D2 radical gastrectomy, and followed by XELOX adjuvant chemotherapy) and control group (standard D2 radical gastrectomy, and followed by XELOX adjuvant chemotherapy). A total of 122 patients from three centers were enrolled from September 2015 to February 2017. Results One hundred and two eligible patients completed the treatment course. The median follow-up time was 41.7 months (36.1–52.9 months). The 3-year progression-free survival rate and overall survival of patients in the intraperitoneal chemotherapy group were 43.9% and 49.1%, respectively, which were significantly better than those of the control group, 31.0% and 38.4%. In the intraperitoneal chemotherapy group, the number of cases with peritoneal recurrence was significantly less than that of the control group, 9 cases (17.3%) vs. 19 cases (44.2%). There were neither significant differences between the groups in the incidence of hematogenous metastasis, lymph node metastasis, nor local metastasis. Conclusion For cTNM stage III gastric cancer, intraoperative sustained-release fluorouracil implants after radical resection combined with postoperative adjuvant chemotherapy, could significantly reduce the risk of peritoneal recurrence and prolong PFS. Clinical Trial Registration https://clinicaltrials.gov/ , identifier (NCT02269904).
    Type of Medium: Online Resource
    ISSN: 2234-943X
    URL: Article
    DOI: 10.3389/fonc.2021.670651
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2021
    detail.hit.zdb_id: 2649216-7
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  • 4
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    Prognostic value of surgical margin status in gastric cancer patients
    Wiley ; 2015
    In:  ANZ Journal of Surgery Vol. 85, No. 9 ( 2015-09), p. 678-684
    Details
    In: ANZ Journal of Surgery, Wiley, Vol. 85, No. 9 ( 2015-09), p. 678-684
    Abstract: It has been reported that positive surgical margin is one of the most significant risk factors for local recurrence and poor survival. However, the survival of gastric cancer ( GC ) patients with positive margin is still controversial. Methods A total of 1025 stage I – III GC patients who underwent gastrectomy with curative intent between J anuary 2003 and A pril 2008 in our centre were enrolled in this study, of whom, 75 patients got a microscopic positive resection margin. Other 950 patients with negative resection margin were used for comparison. Results Borrmann type and extranodal metastasis were independent risk factors for positive margin. The 5‐year overall survival for the patients with positive margin is merely 13.3%. Survival in such patients was similar to that of the patients staged IIIc with R 0 resection. In multivariate analysis, surgical margin status was found to be an independent prognostic factor for GC patients, while histology, tumour location, TNM stage and chemotherapy were independently associated with overall survival for patients with positive margin. Conclusion Surgical margin status is an independent prognostic factor for GC . Patients with positive margin have a poor prognosis, similar to that of IIIc stage disease. When the tumour demonstrates infiltrative growth pattern ( B orrmann type III and IV ) and the surgical margin status is difficult to determine, extended gastrectomy should be implemented to ensure an R 0 resection. Those high‐risk patients should be considered for postoperative chemotherapy.
    Type of Medium: Online Resource
    ISSN: 1445-1433 , 1445-2197
    URL: Issue
    URL: Article
    DOI: 10.1111/ans.2015.85.issue-9
    DOI: 10.1111/ans.12515
    Language: English
    Publisher: Wiley
    Publication Date: 2015
    detail.hit.zdb_id: 2095927-8
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  • 5
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    Phase II study of perioperative toripalimab in combination with FLOT in patients with locally advanced resectable gastric/gastroesophageal junction (GEJ) adenocarcinoma.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 4050-4050
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 4050-4050
    Abstract: 4050 Background: FLOT is the standard perioperative treatment for resectable gastric /gastroesophageal junction (GEJ) adenocarcinoma. However, patient’s outcome is still poor. Toripalimab, a humanized IgG4 monoclonal antibody against programmed cell death receptor-1 (PD-1), has shown remarkable clinical efficacy in various cancers. This trial evaluates the addition of Toripalimab to FLOT for resectable patients. Methods: This is a prospective, single-arm, investigator-initiated phase II trial. Patients with histologically confirmed, resectable, gastric and GEJ adenocarcinoma (≥cT2 or cN+) were enrolled to receive 4 pre-and post-operative cycles of toripalimab (240mg, q2w) plus FLOT (docetaxel 50 mg/m2; oxaliplatin 85 mg/m2; leucovorin 200 mg/m2; 5-FU 2600 mg/m2, q2w). The primary endpoint was pathological complete response rate (pCR). The secondary endpoints included major pathological (complete and nearly complete) response (MPR), and R0-resection rate, 3-year disease-free survival rate, overall survival, and adverse events. Results: In total, of 36 patients were enrolled from June 2019 through Dec 2020. Male, 66.7%; median age, 60y; cT3 8.3%, T4, 83.3%; cN+ 88.9%; GEJ 47%; MSI-H, 5.6%, Her-2neu-positive, 5.6%, EBER-positive, 5.6%). Two patients refused surgery, six patients have not yet completely neoadjuvant treatment. 100% of patients completed the 4 pre-cycle. Patients who had received gastrectomy after neoadjuvant treatment (n=28) were included in this analysis. 6 (21%) patients had operations involving a thoracic approach (oesophagogastrectomy with two field lymphadenectomy), 21 (75%) gastrectomy with D2 lymphadenectomy. 8 (29%) evaluable patients had Clavien-Dindo grade II post-operative complications and 2 (7%) grade IIIA complications; one patient had an anastomotic leakage that was treated endoscopically. There were no emergency re-operations. All 28 patients achieved R0-resection and were discharged home after a median of 12 days (range:7-63) in hospital. 7 （25%）patients achieved pCR (TRG1a) and 12 (42.9%) patients achieved major pathologic response (MPR, TRG1a/b). Treatment-related adverse events (TRAEs) to any drug were reported in 30 (94%) patients. Mostly TRAEs were grade 1-2, the grade 3 or 4 TRAEs included neutropenia (34%), neutropenia (25%), lymphopenia (3%), Alanine aminotransferase increased (3%), hypokalemia (3%) and anaemia (3%). Conclusions: Perioperative toripalimab in combination with FLOT showed promising efficacy with high pCR and MPR rate and well tolerated safety profile in patients with resectable gastric/GEJ adenocarcinoma. This combination regimen might present a new option for patients with locally advanced, resectable gastric/GEJ adenocarcinoma. Clinical trial information: NCT04354662.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.4050
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
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  • 6
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    Methylation of CpG sites in RNF180 DNA promoter prediction poor survival of gastric cancer
    Impact Journals, LLC ; 2014
    In:  Oncotarget Vol. 5, No. 10 ( 2014-05-30), p. 3173-3183
    Details
    In: Oncotarget, Impact Journals, LLC, Vol. 5, No. 10 ( 2014-05-30), p. 3173-3183
    Type of Medium: Online Resource
    ISSN: 1949-2553
    URL: Issue
    URL: Article
    DOI: 10.18632/oncotarget.v5i10
    DOI: 10.18632/oncotarget.1888
    Language: English
    Publisher: Impact Journals, LLC
    Publication Date: 2014
    detail.hit.zdb_id: 2560162-3
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  • 7
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    Expression of Rac1, HIF-1α, and VEGF in Gastric Carcinoma: Correlation with Angiogenesis and Prognosis
    S. Karger AG ; 2013
    In:  Oncology Research and Treatment Vol. 36, No. 3 ( 2013), p. 102-107
    Details
    In: Oncology Research and Treatment, S. Karger AG, Vol. 36, No. 3 ( 2013), p. 102-107
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 The aim of this study was to investigate the relationship between the expression of hypoxia-inducible factor-1α (HIF-1α), Ras-related C3 botulinum toxin substrate 1 (Rac1), and vascular endothelial growth factor (VEGF), as well as their correlation with angiogenesis and prognosis in gastric carcinoma. 〈 b 〉 〈 i 〉 Material and Methods: 〈 /i 〉 〈 /b 〉 The expression of Rac1, HIF-1α, VEGF, and CD34 (described in terms of microvessel density, MVD) was determined by immunohistochemical staining of tissues from 60 radically resected gastric cancer specimens. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The proportion of specimens expressing Rac1, HIF-1α, and VEGF was 37/60 (61.7%), 35/60 (58.3%), and 40/60 (66.7%), respectively. The levels of Rac1, HIF-1α, and VEGF expression were significantly correlated with Lauren's classification, lymph node metastasis, and pathologic staging (p 〈 0.05). There were positive correlations between MVD and the expression of Rac1, HIF-1α, and VEGF. The mean survival time and 5-year survival rate in cases with positive Rac1, HIF-1α, and VEGF expression and MVD ≥ 26.3 were significantly shorter than those with negative Rac1, HIF-1α, and VEGF expression and MVD 〈 26.3. 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 Rac1, HIF-1α, and VEGF play an important role in tumor invasion and metastasis, especially in tumor angiogenesis. Thus, testing the expression of Rac1, HIF-1α, and VEGF may be a useful index for treatment and prognosis.
    Type of Medium: Online Resource
    ISSN: 2296-5270 , 2296-5262
    URL: Article
    DOI: 10.1159/000348525
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2013
    detail.hit.zdb_id: 2749752-5
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  • 8
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    Lymph node metastasis is mediated by suppressor of cytokine signaling-3 in gastric cancer
    Springer Science and Business Media LLC ; 2013
    In:  Tumor Biology Vol. 34, No. 6 ( 2013-12), p. 3627-3636
    Details
    In: Tumor Biology, Springer Science and Business Media LLC, Vol. 34, No. 6 ( 2013-12), p. 3627-3636
    Type of Medium: Online Resource
    ISSN: 1010-4283 , 1423-0380
    URL: Article
    DOI: 10.1007/s13277-013-0944-3
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2013
    detail.hit.zdb_id: 605825-5
    detail.hit.zdb_id: 1483579-4
    SSG: 12
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  • 9
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    Comparison of the staging of regional lymph nodes using the sixth and seventh editions of the tumor-node-metastasis (TNM) classification system for the evaluation of overall survival in gastric cancer patients: Findings of a case-control analysis involving a single institution in China
    Elsevier BV ; 2014
    In:  Surgery Vol. 156, No. 1 ( 2014-07), p. 64-74
    Details
    In: Surgery, Elsevier BV, Vol. 156, No. 1 ( 2014-07), p. 64-74
    Type of Medium: Online Resource
    ISSN: 0039-6060
    URL: Article
    DOI: 10.1016/j.surg.2014.03.020
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2014
    detail.hit.zdb_id: 2018278-8
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  • 10
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    Vascular endothelial growth factor-D is correlated with hepatic metastasis from gastric cancer after radical gastrectomy
    Elsevier BV ; 2009
    In:  Surgery Vol. 146, No. 5 ( 2009-11), p. 896-905
    Details
    In: Surgery, Elsevier BV, Vol. 146, No. 5 ( 2009-11), p. 896-905
    Type of Medium: Online Resource
    ISSN: 0039-6060
    URL: Article
    DOI: 10.1016/j.surg.2009.04.025
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2009
    detail.hit.zdb_id: 2018278-8
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