Efficacy and Safety of SOX Regimen Combined With Camrelizumab as Neoadjuvant Treatment in Locally Advanced Gastric Cancer: a Phase II, Single-arm Study

NCT05602935 | Active Not Recruiting Phase 2

• 1 other identifier: NEO-GASTRIC
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, phase II study of camrelizumab combined with SOX regimen in subjects with resectable locally advanced gastric cancer. The patients will receive camrelizumab ,S-1 and oxaliplatin given every 3 weeks for 3 cycles as neoadjuvant therapy. After the surgery, adjuvant therapy which includes camrelizumab and SOX regimen will begin.

Conditions

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

Keywords

gastric cancer; neoadjuvant chemoimmunotherapy; neoadjuvant immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response (pCR) rate

  The AJCC TRG system was used in this study to determine the effects of treatment. TRG 0 indicating athologic complete response (pCR)

  2-4 months

Secondary Outcomes (7)

• R0 resection rate

  2-4 months

• Overall response rate(ORR)

  2-4 months

• Disease control rate(DCR)

  2-4 months

• Major pathological response (MPR)

  2-4 months

• Adverse events (AE) rate

  3 years

Study Arms (1)

Camrelizumab+SOX

EXPERIMENTAL

The patients in the experimental arm will receive camrelizumab concurrently with SOX(S-1 and oxaliplatin).

Drug: Camrelizumab; Drug: SOX; Procedure: Surgery

Interventions

Camrelizumab DRUG

200mg, intravenously, d1

Camrelizumab+SOX

SOX DRUG

SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

Camrelizumab+SOX

Surgery PROCEDURE

Surgery

Camrelizumab+SOX

Eligibility Criteria

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

You may qualify if:

• Age older than 18 years of age;
• Histologically or cytological confirmed gastric or gastroesophageal junction adenocarcinoma;
• Without prior systematic therapy;
• The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1;
• With measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
• Clinically diagnosed stage cT3-4bN1-3M0 evaluated by CT/MRI/EUS;
• Life expectancy longer than 12 months;
• Adequate function of blood, heart, liver, kidney and thyroid.

You may not qualify if:

• History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or history of organ transplantation or allogeneic bone marrow transplantation;
• Unresectable tumor evaluated by investigator;
• Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) heart failure with NYHA class II or above (2) unstable angina, （3）myocardial infarction occurred within 1 year (4) clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention;
• With tumors in other sites;
• Has a history of allergy to monoclonal antibody, any component of PD-1 Inhibitor, S-1 and oxaliplatin;
• With any mental illness;
• Pregnant or lactating women.

Sponsors & Collaborators

• The Second Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Related Publications (1)

• Zhong WJ, Lin JA, Wu CY, Wang J, Chen JX, Zheng H, Ye K. Efficacy and safety of camrelizumab combined with oxaliplatin and S-1 as neoadjuvant treatment in locally advanced gastric or gastroesophageal junction cancer: A phase II, single-arm study. Cancer Med. 2024 Feb;13(3):e7006. doi: 10.1002/cam4.7006.

  PMID: 38400680 DERIVED

MeSH Terms

Conditions

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

Interventions

camrelizumab; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Gastrointestinal Diseases

Study Design

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

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 2, 2022
• Study Start: September 16, 2020
• Primary Completion: March 30, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 28, 2023

Record last verified: 2022-11

Locations

CN (1)