PD-1 Antibody Combined With Modified FLOT Regimen in the Treatment of Unresectable Locally Advanced or Limited Metastatic Gastric Cancer

Metastatic Gastric Cancer Clinical Trial

Official title: Phase II Clinical Study of PD-1 Antibody Camrelizumab Combined With Modified FLOT Regimen in the Treatment of Unresectable Locally Advanced or Localized Metastatic Gastric Cancer

Status Recruiting

Clinical Trial Summary

This study is to evaluate the efficacy and safety of domestic programmed death 1（ PD-1） antibody (Camrelizumab for injection) combined with fluorouracil plus leucovorin, oxaliplatin, and albumin bound paclitaxel (modified FLOT, mFLOT) regimen in the treatment of patients with unresectable locally advanced or limited metastatic gastric cancer. The primary efficacy endpoint is R0 resection rate.

Clinical Trial Description

This is an open, single center, prospective phase II clinical study to evaluate the efficacy and safety of domestic PD1 antibody (Camrelizumab for injection) combined with mFLOT regimen in the treatment of unresectable locally advanced or limited metastatic gastric cancer. This study will be carried out in our center, about 40 patients will be enrolled.

Patients with unresectable locally advanced or limited metastatic gastric cancer who had not received any prior antitumor therapies were treated with domestic PD1 antibody (Caerelizumab for injection) commbined with mFLOT regimen, and human epidermal-growth-factor receptor 2 (HER-2) positive patients were treated with Herceptin. The efficacy of therapy was evaluated every 3 treatment cycles. After 6 cycles, surgical experts evaluated the resectability of the tumor, and the patients who were confirmed to be resectable received surgery within 3-6 weeks after immunochemotherapy. The patients with good postoperative recovery continued to receive the same immunochemotherapy in 3-6 weeks, and totally at most 12 cycles. Patients who were evaluated as progressive disease (PD) at any time withdrawn from the study as conversion failure.Patients who did not PD at 6 cycles of treatment but did not reach the criteria for R0 resection, continued to receive another 3 cycles of the prior chemotherapy. If resectable then, surgical treatment was performed, if still unresectable, the immunochemotherapy for transformation was evaluated as unsuccessful. The patients were treated according to the principle of palliative treatment until the disease progressed or intolerable toxicity. The efficacy and safety will be continuously monitored and evaluated throughout the study period (including a 30 day follow-up period). 40 cases were expected to be enrolled: 3-4 cases per month, completed in 1 year and finished in 2 years. ;

Related Conditions & MeSH terms

• Locally Advanced Gastric Adenocarcinoma
• Metastatic Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT04510064
• Study type: Interventional
• Source: Fudan University
• Contact: weijian guo, professor
• Phone: +86-21-64175590
• Email: guoweijian@hotmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2020
• Completion date: August 2022