SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma

NCT03950271 | Active Not Recruiting Phase 2

• 1 other identifier: GCCG7
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete response (pCR) rate

  the rate of no residual tumor cells in both the excised gastric cancer and lymph node (ypT0N0)

  up to 2 year

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  up to 2 year

• Overall survival(OS)

  up to 2 year

• safety

  up to 2 year

• Disease Free Survival（DFS）

  up to 2 year

Study Arms (1)

SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine

EXPERIMENTAL

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.

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

Interventions

SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine DRUG

1. Neoadjuvant chemotherapy： SHR-1210 (200mg, d1, q3w) + trastuzumab ( 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) + capecitabine (1000mg/m2 bid d2-15, q3w) + Oxaliplatin (130mg/m2, d2, q3w)；4cycle 2. postoperative adjuvant chemotherapy： Capecitabine (1000mg/m2 bid d1-14, q3w) + oxaliplatin (130mg/m2, d1, q3w)；The total number of chemotherapy cycles is 8 cycles.

SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine

Eligibility Criteria

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

You may qualify if:

• Signed the informed consent form
• 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
• ECOG≤1
• 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.
• serum creatinine ≤ 1.5ULN, or GFR \> 45 ml / min
• serum albumin ≥ 25 g / L (2.5 g / dL)
• INR or APTT ≤ 1.5 ULN
• Hepatitis B surface antigen positive patients need to detect hepatitis B DNA virus quantitative detection, only patients below the upper limit of normal detection can be enrolled, and long-term use ofanti-hepatitis B virus drugs

You may not qualify if:

• 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
• Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to the start of the trial. Inhaled corticosteroids and mineralocorticoids are allowed
• Hormone use contraindications。
• severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the test
• Uncontrollable increase in blood pressure or elevated blood sugar
• History of other malignant tumors 5 years ago, except for cervical cancer in situ, non-melanoma skin cancer or stage I uterine cancer

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Trastuzumab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

Study Officials

• Suxia Luo

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: January 20, 2020
• Primary Completion: January 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-01

Locations

CN (1)