Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma

Henan Cancer Hospital1 site in 1 country25 target enrollmentJanuary 20, 2020

ConditionsGastric Cancer

InterventionsSHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine

DrugsSHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine

Overview

Phase: Phase 2
Intervention: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine
Conditions: Gastric Cancer
Sponsor: Henan Cancer Hospital
Enrollment: 25
Locations: 1
Primary Endpoint: pathological complete response (pCR) rate
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Detailed Description

This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment.

Registry

clinicaltrials.gov

Start Date

January 20, 2020

End Date

December 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Henan Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed the informed consent form
•18-75 years old
•Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (cT4 or / and N+M0, MDT believes that perioperative treatment is required):
•No peritoneal metastasis in CT
•evaluated as a resectable lesion. Note: Whether there is a distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If there is suspected peritoneal metastasis, a laparoscopy should be performed. If brain metastasis is suspected, CT or MR examination should be performed.
•Have not received cytotoxic chemotherapy or targeted therapy and local tumor resection
•HER2 immunohistochemistry 3+ and fluorescence in situ hybridization showed significant amplification
•Tumor specimens that can be used to detect PD-L1 and MSI status can be provided. Detection of PD-L1 and MSI will be performed after enrollment. This test requires patients to provide paraffin-embedded biopsy specimens.
•White blood cells ≥ 4×109/L, platelets without blood transfusion ≥ 100×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L without granulocyte stimulating factor, hemoglobin ≥ 90 g/L
•bilirubin ≤ 1.5 times the upper limit of normal value, cereal grass and alanine aminotransferase ≤ 2.5ULN. If there is liver metastasis, the grass and alanine aminotransferase ≤ 5ULN.

Exclusion Criteria

•Allergic to any test drug and its excipients, or have a history of severe allergies, or a contraindication to test drugs
•Have a history of autoimmune disease or be active
•Previously received allogeneic bone marrow transplantation or organ transplantation
•Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia
•HIV test positive
•Active hepatitis B or hepatitis C
•Active tuberculosis
•Uncontrolled cancer pain
•A live attenuated vaccine is injected within 4 weeks before the start of the study, or it is expected that a live attenuated vaccine will be injected within 5 months after the trial or the end of the trial.
•Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PDL1 mAb

Arms & Interventions

SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine

trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.

Intervention: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine