NCT05800080

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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。

Detailed 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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy;Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy	one group receives peri operative treatment of Penpulimab combined with Anlotinib Hydrochloride Capsules and chemotherapy, and the other group receives peri operative treatment of Cadonilimab combined with Anlotinib Hydrochloride Capsules and chemotherapy.After receiving corresponding neoadjuvant treatment for 3 cycles according to the established treatment plan, surgical treatment shall be carried out within 3-6 weeks after drug withdrawal

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2023-04-05
• Last updated: 2023-04-05

Locations

1 site across 1 country: China