Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

NCT04119622 | Unknown Phase 2

• 1 other identifier: JS001-ISS-CO63
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastric Cancer Stage II; Gastric Cancer Stage III

Keywords

Toripalimab; JS001; Gastric Cancer; neoadjvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Major pathological response rate

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

  Up to 6 months

Secondary Outcomes (5)

• Incicende of Adverse Events (AEs)

  Up to 6 months

• Pathologic Complete Response (pCR) Rate

  Up to 6 months

• Overall Response Rate (ORR)

  Up to 6 months

• Disease Free Survival (DFS)

  Up to 5 years

• Overall Survival (OS)

  Up to 5 years

Study Arms (1)

XELOX combined with Toripalimab

EXPERIMENTAL

Drug: Toripalimab; Drug: oxaliplatin; Drug: capecitabine

Interventions

Toripalimab DRUG

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

XELOX combined with Toripalimab

oxaliplatin DRUG

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

XELOX combined with Toripalimab

capecitabine DRUG

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

XELOX combined with Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, siwert type I was excluded.
• Clinical determined T3/4 N any or T 1/2 N 2/3 referred to AJCC 8, based on CT, gastroscopy, endoscopic ultrasound, gastrointestinal angiography, general ultrasound, or laparoscope if the patient can afford.
• No prior chemotherapy and/or immunotherapy and/or radiation therapy.
• Age 18 to 75 years old.
• ECOG 0 or 1 .
• Adequate Organ Function Laboratory Values Hb≥90g/L, WBC≥3.5×109 /L, ANC≥1.5×109 /L, Platelets≥100×109 /L Serum creatinine ≤1.0×ULN ALT≤1.5 ×UNL , AST ≤1.5×ULN，ALP≤ 1.5 ×ULN Serum total bilirubin ≤1.5 × ULN
• Signed Informed consent

You may not qualify if:

• Pathology types other than adenocarcinoma, such as squamous cell carcinoma.
• intra-abdominal dissemination or distant metastasis (M1).
• Digestive tract obstruction or repeated bleeding which can not be controlled, clinically significant ascites.
• Those who cannot swallow pills.
• Cirrhosis caused by any cause.
• Heart function NYHA \> I degree
• Previous myocardial infarction, unstable angina, stroke and uncontrolled arrhythmia.
• with any contraindications for surgery.
• Previously received chemotherapy and or radiation therapy.
• Previously received any anti-PD 1 , anti - PD L1/L2 antibodies, anti-CTLA 4 antibodies and other immunotherapy.
• Previously received other anti-tumor treatments.
• History of surgical resection for gastric cancer.
• Have had other tumors in the past, except for cured skin cancer and cervical cancer in situ.
• Accompanied by systemic diseases which cannot meet the conditions of chemotherapy.
• Pregnancy and lactating patients.

Sponsors & Collaborators

• Aiping Zhou: lead

Study Sites (2)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Chinese Academy of Medical Sciences

Beijing, 10000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

toripalimab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Aiping Zhou, doctor

CONTACT

+86 13691161998; zhouap1825@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: October 8, 2019
• Primary Completion: September 30, 2022
• Study Completion: October 1, 2024
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

CN (2)