NCT04119622

Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage II/III Gastric or GE Junction Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aiping Zhou · Unknown
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy. PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.

Detailed description

This phase II trial is a single-arm, open Label, non-randomized and single-center clinical study. Patients who met the study criteria will receive the combination of toripalimab (240 mg d1) with XELOX (oxaliplatin 130 mg/m2 QD, d1, capecitabine 1000 mg/m2 BID, d1-d14) of a 3-week treatment cycle up to two cycles. After the second cycle of treatment, clinical efficacy evaluation will be done by MDT according to iRECIST. For patients with CR/PR/SD, surgery will be performed within 4 weeks. For patients with disease progress, MDT will determine whether the surgery could be performed. If resection could not be done, the patients would receive Original chemotherapy with toripalimab for 1 more cycle, chemoradiotherapy or the second line chemotherapy. The primary endpoint is Major pathological response.

Conditions

• Gastric Cancer Stage II
• Gastric Cancer Stage III

Interventions

Type	Name	Description
DRUG	Toripalimab	toripalimab 240 mg d1; q3w, up to two cycles.
DRUG	oxaliplatin	oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles
DRUG	capecitabine	apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles

Timeline

• Start date: 2019-10-08
• Primary completion: 2022-09-30
• Completion: 2024-10-01
• First posted: 2019-10-08
• Last updated: 2022-03-11

Locations

2 sites across 1 country: China