A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer

NCT06485271 | Recruiting

• 1 other identifier: Gastric cancer-RWS
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment

Conditions

Gastric Cancer; RWS; PD-1 Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The percentage of subjects achieving complete or partial response in a real-world clinical setting.

  24 months

Secondary Outcomes (3)

• Progression free survival

  24 months

• Disease control rate

  24 months

• Overall survival

  24 months

Study Arms (3)

cohort 1

First-line

Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy

cohort 2

Second-line

Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy

cohort 3

Third-line and above

Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy

Interventions

Camrelizumab DRUG

200mg,iv,d1,Q2W/Q3W

cohort 1; cohort 2; cohort 3

apatinib DRUG

250mg,qd

cohort 1; cohort 2; cohort 3

chemotherapy DRUG

Standard treatment

cohort 1; cohort 2; cohort 3

Eligibility Criteria

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

Study Population

Patients with advanced gastric cancer confirmed by pathology or histology

You may qualify if:

• Age ≥18 years old, both male and female;
• patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment;
• Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CT or MR target lesion should be ≥10 mm and lymph node ≥15 mm;
• The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
• Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

You may not qualify if:

• Pregnant or lactating women;
• Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);
• Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);

Sponsors & Collaborators

• Changzhi People's Hospital Affiliated to Changzhi Medical College: lead

Study Sites (1)

Changzhi People's Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

camrelizumab; apatinib; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)