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RecruitingNCT06485271Updated Jul 3, 2024

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

An observational study in Gastric Cancer, RWS and PD-1 Immunotherapy, sponsored by Changzhi People's Hospital Affiliated to Changzhi Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Changzhi People's Hospital Affiliated to Changzhi Medical College · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
504
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gastric Cancer
  • RWS
  • PD-1 Immunotherapy

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 504 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Changzhi People's Hospital Affiliated to Changzhi Medical College is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with advanced gastric cancer confirmed by pathology or histology

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
504 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugCamrelizumab

    200mg,iv,d1,Q2W/Q3W

  • Drugapatinib

    250mg,qd

  • Drugchemotherapy

    Standard treatment

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Changzhi People's Hospital Affiliated to Changzhi Medical College
    Changzhi, Shanxi, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06485271
Lead sponsor
Changzhi People's Hospital Affiliated to Changzhi Medical College
Responsible party
Sponsor
First posted
Jul 3, 2024
Start date
Nov 1, 2023
Primary completion
Oct 2025 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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