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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; PD-1 Immunotherapy; RWS
• Intervention / Treatment: Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy

• Study Type: Observational
• Enrollment (Estimated): 504

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Changzhi, Shanxi, China
      • Recruiting
      • Changzhi People's Hospital Affiliated to Changzhi Medical College
      • Contact: YunYi Du; Phone Number: 0355-2024990; Email: duyunyi131@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with advanced gastric cancer confirmed by pathology or histology

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort 1; First-line	Drug: Camrelizumab; 200mg,iv,d1,Q2W/Q3W; Drug: apatinib; 250mg,qd; Drug: chemotherapy; Standard treatment
cohort 2; Second-line	Drug: Camrelizumab; 200mg,iv,d1,Q2W/Q3W; Drug: apatinib; 250mg,qd; Drug: chemotherapy; Standard treatment
cohort 3; Third-line and above	Drug: Camrelizumab; 200mg,iv,d1,Q2W/Q3W; Drug: apatinib; 250mg,qd; Drug: chemotherapy; Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The percentage of subjects achieving complete or partial response in a real-world clinical setting.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	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.	24 months
Disease control rate	The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.	24 months
Overall survival	From date of admission until the date of death from any cause, assessed up to 24 months.	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Gastric cancer-RWS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No