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

NCT ID: NCT06485271

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 504 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-10-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cohort 1

First-line

Camrelizumab

Intervention Type: DRUG

200mg,iv,d1,Q2W/Q3W

apatinib

Intervention Type: DRUG

250mg,qd

chemotherapy

Intervention Type: DRUG

Standard treatment

cohort 2

Second-line

Camrelizumab

Intervention Type: DRUG

200mg,iv,d1,Q2W/Q3W

apatinib

Intervention Type: DRUG

250mg,qd

chemotherapy

Intervention Type: DRUG

Standard treatment

cohort 3

Third-line and above

Camrelizumab

Intervention Type: DRUG

200mg,iv,d1,Q2W/Q3W

apatinib

Intervention Type: DRUG

250mg,qd

chemotherapy

Intervention Type: DRUG

Standard treatment

Interventions

Camrelizumab

200mg,iv,d1,Q2W/Q3W

Intervention Type: DRUG

apatinib

250mg,qd

Intervention Type: DRUG

chemotherapy

Standard treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, both male and female;

2. 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;

3. 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;

4. The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;

5. Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion Criteria

1. Pregnant or lactating women;

2. Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);

3. Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);

4. Patients who, in the judgment of the investigator, are not suitable for inclusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changzhi People's Hospital Affiliated to Changzhi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changzhi People's Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

YunYi Du

Role: primary

duyunyi131@126.com

0355-2024990

Other Identifiers

Gastric cancer-RWS

Identifier Type: -

Identifier Source: org_study_id