Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer

NCT04367025 | Unknown Phase 2

• 1 other identifier: OBU-BJ-GC-II-007
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab（SHR-1210） in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma. This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.

Conditions

Gastric Cancer

Keywords

Gastric cancer; Camrelizumab; neoadjuvant; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  It is defined as residual tumors less than 10% after neoadjuvant chemotherapy.

  At time of surgery

Secondary Outcomes (5)

• Objective response rate(ORR)

  From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

• pCR

  From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks

• Disease-free survival (DFS)

  3years

• Overall survival(OS)

  From the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years

• OSR

  3years

Study Arms (2)

SOX

ACTIVE COMPARATOR

SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 2-4 cycles

Drug: Oxaliplatin; Drug: S1

Camrelizumab+ SOX

EXPERIMENTAL

Camrelizumab:200mg,iv drip for 1h,d1,q3w SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Neoadjuvant chemotherapy+ Camrelizumab for 2-4 cycles, adjuvant chemotherapy + Camrelizumab for 2-4 cycles.

Drug: Camrelizumab; Drug: Oxaliplatin

Interventions

Camrelizumab DRUG

Camrelizumab: 200mg,iv drip for 1h,d1,q3w

Also known as: SHR-1210

Camrelizumab+ SOX

Oxaliplatin DRUG

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;

Also known as: OXA

Camrelizumab+ SOX; SOX

S1 DRUG

S-1:40\~60mg Bid, d1\~14, q3w;

SOX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written (signed) informed consent.
• Age ≥ 18 years and ≤70 years.
• ECOG Performance status 0-1.
• Has previously untreated localized gastric or gastroesophageal junction adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease.
• Patients who plan surgery after neoadjuvant chemotherapy based on clinical staging criteria.
• Consent to send tumor tissue from biopsy or resection for PD-L1 detection and PD-L1 CPS≥1;
• Expected survival ≥6 months;
• Females of child bearing age must have a negative pregnancy test
• ）Platelet (PLT) ≥100×109/L; 2) Neutrophil count (ANC)≥1.5×l09/L; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4）WBC≥3.5×l09/L; 5) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) ,International Normalized Ratio（INR）and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6）Total bilirubin (TBIL) level ≤1.5×ULN（patients with gilbert syndrome≤3×ULN）; 7) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN ; 10) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min;

You may not qualify if:

• Patients with pathologically confirmed gastric squamous cell carcinoma, adenosquamous carcinoma, small cell carcinoma, and undifferentiated gastric cancer.
• patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive.
• Patients with a history of t Anticancer or Experimental Therapy(Including chemotherapy, radiotherapy, hormone therapy and molecular targeted therapy)
• The patient's cardia or pylorus is nearly obstructed, affecting eating and gastric emptying
• Immunotherapy with previous anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that targets T-cell co-stimulation or immune checkpoint pathways
• Patients have experienced or currently has other malignancies within 5 years.Except for the cured cervical carcinoma in situ,Non-melanoma skin cancer, Other tumors or cancers that have been treated radically and have shown no signs of disease for at least 5 years.
• Peripheral neuropathy ≥ level 2（according to CTCAE 5.0）
• Patient currently has CNS or cancerous meningitis.
• Patients are allergic to study medication and its ingredients
• Patients have hereditary bleeding or coagulopathy at risk of bleeding
• Patient underwent major surgery within 4 weeks
• Patients have taken Chinese herbal medicine or proprietary Chinese medicine for cancer treatment within two weeks
• Patients have not recovered from complications of previous surgery.According to the CTCAE 5.0, it has not been reduced below level 1(In addition to hair loss and fatigue)
• Patients require immunosuppressive drugs within 2 weeks or less or during the study.Exclude the following:
• A) Use of intranasal, inhaled or topical steroid(For example, intra - articular injection) B) physiological dose of steroid ( Prednisone less than 10mg per day or use equivalent dose) C) Short-term(no more than 7 day) use of steroids to prevent or treat non-autoimmune allergic diseases

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; Oxaliplatin; S 1 (combination)

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

Central Study Contacts

Baoqing Jia, professor

CONTACT

+861066937523; baoqingjia@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 29, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

CN (1)