Gastric CancerNCT06485271
A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
An observational study of Gastric Cancer and RWS, run by Changzhi People's Hospital Affiliated to Changzhi Medical College at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, RWS, PD-1 Immunotherapy
- What is being tested?
- Camrelizumab, apatinib and chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced gastric cancer confirmed by pathology or histology
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzhi People's Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
YunYi Du, 0355-2024990, duyunyi131@126.com
About this study
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
- Conditions
- Gastric Cancer, RWS, PD-1 Immunotherapy
- Being tested
- Camrelizumab, apatinib, chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
200mg,iv,d1,Q2W/Q3W
apatinibDrug
250mg,qd
chemotherapyDrug
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | First-line Receives: Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy | |
| cohort 2 | Second-line Receives: Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy | |
| cohort 3 | Third-line and above Receives: Drug: Camrelizumab; Drug: apatinib; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The percentage of subjects achieving complete or partial response in a real-world clinical setting.
Measured: 24 months
Secondary outcomes (3)
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.
Measured: 24 months
Disease control rate
The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.
Measured: 24 months
Overall survival
From date of admission until the date of death from any cause, assessed up to 24 months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485271
- Sponsor's protocol ID
- Gastric cancer-RWS
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06485271
- Acronym / sponsor ID
- Gastric cancer-RWS
- Conditions
- Gastric Cancer, RWS, PD-1 Immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Changzhi People's Hospital Affiliated to Changzhi Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | – | Drug: Camrelizumab, Drug: apatinib, Drug: chemotherapyFirst-line |
| cohort 2 | – | Drug: Camrelizumab, Drug: apatinib, Drug: chemotherapySecond-line |
| cohort 3 | – | Drug: Camrelizumab, Drug: apatinib, Drug: chemotherapyThird-line and above |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced gastric cancer confirmed by pathology or histology
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab200mg,iv,d1,Q2W/Q3W | Drug | cohort 1, cohort 2, cohort 3 |
| apatinib250mg,qd | Drug | cohort 1, cohort 2, cohort 3 |
| chemotherapyStandard treatment | Drug | cohort 1, cohort 2, cohort 3 |
Primary outcome
Objective response rate
Time frame: 24 months
The percentage of subjects achieving complete or partial response in a real-world clinical setting.
3 secondary outcomes
Progression free survival
Time frame: 24 months
Disease control rate
Time frame: 24 months
Overall survival
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changzhi People's Hospital Affiliated to Changzhi Medical College
Changzhi, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and RWS, run by Changzhi People's Hospital Affiliated to Changzhi Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.