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

Recruiting

• Conditions: RWS; Gastric Cancer; PD-1 Immunotherapy
• Interventions: Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy

• Registration Number: NCT06485271
• Lead Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Last Update Submitted: 2024-06-26
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 504

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort 3	chemotherapy	Third-line and above
cohort 2	chemotherapy	Second-line
cohort 1	chemotherapy	First-line
cohort 1	apatinib	First-line
cohort 3	apatinib	Third-line and above
cohort 1	Camrelizumab	First-line
cohort 2	apatinib	Second-line
cohort 2	Camrelizumab	Second-line
cohort 3	Camrelizumab	Third-line and above

Primary Outcome Measures

Name	Time	Method
Objective response rate	24 months	The percentage of subjects achieving complete or partial response in a real-world clinical setting.

Secondary Outcome Measures

Name	Time	Method
Overall survival	24 months	From date of admission until the date of death from any cause, assessed up to 24 months.
Disease control rate	24 months	The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.
Progression free survival	24 months	From date of admission until the date of first documented progression in the real-world setting or date of death from any cause, whichever came first, assessed up to 24 months.

Trial Locations

Locations (1)

Changzhi People's Hospital Affiliated to Changzhi Medical College; 🇨🇳 Changzhi, Shanxi, China