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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChangzhi People's Hospital Affiliated to Changzhi Medical College

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.);

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

Trial population

Patients with advanced gastric cancer confirmed by pathology or histology

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Camrelizumab

    Drug

    200mg,iv,d1,Q2W/Q3W

  • apatinib

    Drug

    250mg,qd

  • chemotherapy

    Drug

    Standard treatment

Treatment groups

504 Participants
are divided into 3 treatment groups
Group A: cohort 13 interventions
Group B: cohort 23 interventions
Group C: cohort 33 interventions

Trial outcomes

Primary outcomes

1

Objective response rate

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

Time frame
24 months

Secondary outcomes

1

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.

Time frame
24 months
2

Disease control rate

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

Time frame
24 months
3

Overall survival

From date of admission until the date of death from any cause, assessed up to 24 months.

Time frame
24 months

Other outcomes

Sponsors and contacts

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