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NCT Number: NCT06485271

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changzhi People's Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Location status: Recruiting

Location contact

YunYi Du

CONTACT

[email protected]

0355-2024990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Camrelizumab

Drug

200mg,iv,d1,Q2W/Q3W

apatinib

Drug

250mg,qd

Chemotherapy

Drug

Standard treatment

Primary outcomes

  1. Objective response rate

    Time frame: 24 months

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

Secondary outcomes

  1. Progression free survival

    Time frame: 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.

  2. Disease control rate

    Time frame: 24 months

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

  3. Overall survival

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

Changzhi People's Hospital Affiliated to Changzhi Medical College

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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