Neoplasms

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Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

toripalimab 240 mg d1; q3w, up to two cycles.

Toripalimab

oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles

oxaliplatin

apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles

capecitabine

Aiping Zhou, doctor

Aiping Zhou, MD

Ai ping Zhou

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.

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.

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

Proportion of subjects with residual tumor less than 10% or complete response

Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.

Proportion of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.

Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) according to iRECIST

Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.

Time from Cycle 1 Day 1 treatment administration to death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer	NCT04119622	Gastric Cancer ... Gastric Cancer ...	Toripalimab oxaliplatin capecitabine	18 Years - 75 Years	ChineseAMS
Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer	NCT04119622	Gastric Cancer ... Gastric Cancer ...	Toripalimab oxaliplatin capecitabine	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for neoadjvant chemotherapy