An Exploratory Study of Immunotherapy Combined With Anlotinib and Chemotherapy in Perioperative Treatment of LAGC

Gastric Cancer Clinical Trial

Official title: An Exploratory Study of Immunotherapy Combined With Anlotinib Hydrochloride Capsules and Chemotherapy in Perioperative Treatment of Locally Advanced Novel Coronavirus Infected Gastric Cancer

Status Not yet recruiting

Clinical Trial Summary

• 1. Main objective: to evaluate the pathological complete response (pCR) of gastric cancer after local advanced COVID-19 infection by two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy.

• 2. Secondary objective: to evaluate the major pathological response (MPR), disease-free survival (DFS), objective response rate (ORR), R0 resection rate (R0 resection rate) and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and neoadjuvant chemotherapy for gastric cancer after local advanced COVID-19 infection。

Clinical Trial Description

This is a prospective multicenter exploratory study to evaluate the efficacy and safety of two kinds of immunotherapy combined with Anlotinib Hydrochloride Capsules and chemotherapy for resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer after COVID-19 infection This study was led by Professor Hongliu, Department of Gastroenterology, Xijing Hospital. 114 patients with resectable or potentially resectable T3~4N+M0 locally advanced gastric cancer were planned to be randomly divided into two groups: one group received peri-operative treatment with Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group received peri-operative treatment with Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy. Each subject will receive three cycles of neoadjuvant study treatment: Pianzumab (single immunity, fixed dose 200mg) or Cadonilimab (double immunity, fixed dose 500mg), which will be administered on the first day of each cycle and repeated every three weeks; Anlotinib Hydrochloride Capsules: 12mg, administered on the 1-14th day of each cycle, once a day, about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every 3 weeks; Tegafur: It needs to be administered according to the patient's body surface area< 40 mg/time at 1.25 m2; ≥ 50 mg/time when 1.25m2 and<1.5 m2; ≥ 60 mg/time at 1.5 m2; Take orally, twice a day, after breakfast and dinner, for 14 consecutive days, and rest for 7 days, which is a treatment cycle; Repeat once every 3 weeks; Oxaliplatin: 130 mg/m2, administered on the first day of each cycle, repeated every three weeks. ;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

• NCT number: NCT05800080
• Study type: Interventional
• Source: Xijing Hospital
• Contact: Liu Hong
• Phone: +86-13709284513
• Email: hongliu1@fmmu.edu.cn
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Completion date: February 2025