Gastric CancerPhase 2NCT06792162
PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer
A Phase 2 study testing Carilizumab and Apatinib in people with Gastric Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
Evaluate the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Carilizumab and Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years old, gender not limited;
- Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric adenocarcinoma (GC) (excluding neuroendocrine tumors) or gastroesophageal junction adenocarcinoma (GEJ);
- Unresectable gastric cancer patients with potential for conversion therapy, defined as gastric cancer patients with single organ metastasis (such as liver metastasis, ovarian metastasis, lung metastasis), retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, localized peritoneal metastasis, invasion of surrounding organs, and other gastric cancer patients evaluated by researchers as feasible for conversion therapy;
- Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor.
- ECOG PS score 0-1 points;
- Expected survival period ≥ 3 months;
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- The main organ functions are normal, and there are no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases.
- Normal coagulation function, no active bleeding or thrombotic diseases:
- The time from the end of traditional Chinese medicine, traditional Chinese patent medicines and simple preparations and immunomodulator (such as thymosin, interleukin, etc.) that have used anti-tumor drugs in the past to the start of the study must be ≥ 2 weeks;
- Non surgical sterilization or female subjects of childbearing age are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 180 days after the end of the study treatment; Female subjects of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours prior to randomization; And it must be during non lactation period; For male participants whose partners are women of childbearing age, effective contraception methods should be used during the study treatment period and within 180 days after the end of the study treatment period.
- Subjects voluntarily participated in this study, fully understood and informed of the study, and signed the Informed Consent Form (ICF);
Who cannot join
- Other malignant tumors have been diagnosed within 5 years before the first use of the investigational drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma and/or effectively resected cervical carcinoma in situ and/or breast cancer and/or thyroid cancer and other malignant tumors that have achieved long-term survival;
- Suffering from any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (except for patients with stable hormone levels after treatment); Subjects with childhood asthma who have been completely relieved and do not require any intervention or vitiligo in adulthood may be included, but those who require medical intervention with bronchodilators may not be included;
- People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with co infection of hepatitis B and hepatitis C;
- Within 14 days prior to the first use of the investigational drug, immunosuppressive drugs have been used, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs);
- Vaccination with attenuated live vaccine within 4 weeks before the first administration or planned during the study period;
- Patients with hypertension who cannot be reduced to normal range by antihypertensive medication (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg);
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- Suffering from uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) poorly controlled arrhythmia;
- Patients who have had or currently have interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc., and whose lung function is severely impaired, which may interfere with the detection and management of suspected drug-related pulmonary toxicity;
- suffer from active pulmonary tuberculosis;
- Severe infection (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first medication, or unexplained fever (body temperature ≥ 38.5 ° C) during the screening period/before the first administration;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Those who are known to have a history of allergies to the components of this drug regimen;
- There is a possibility of increasing participation in research and medication risks, or other severe, acute, and chronic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University third hospital
Beijing
Yanhong Yao, snowdream246@163.com
About this study
Official title: Single Center, Phase II Clinical Study of PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer
Evaluate the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
Read the detailed description
This study is a prospective, open label, single center, phase II clinical trial aimed at evaluating the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
The study participants were unresectable stage III and IV dMMR gastric cancer patients who had not undergone any anti-tumor treatment. The study aims to enroll 20 participants with a primary endpoint of 1-year disease progression free survival rate. participants who meet the inclusion criteria will receive treatment with both Carilizumab and Apatinib, repeated every 21 days. During the conversion therapy period, the researchers evaluate whether surgery can be performed after every 2 cycles of medication for the subjects. After evaluation by the researchers, the participants were deemed eligible for surgery. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical subjects will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years.
After the treatment is completed, a treatment end visit, a post treatment safety visit, and survival follow-up will be conducted. Participants who end the study due to non disease progression reasons will undergo imaging evaluation at the end of treatment (if no imaging evaluation has been received within 4 weeks before the end of treatment), and imaging evaluation will be conducted every 2 months after the end of treatment to assess the time of disease progression. After the completion of treatment, the participants will undergo a survival follow-up every 90 days to collect and record their survival status and subsequent anti-tumor treatment.
- Conditions
- Gastric Cancer
- Being tested
- Carilizumab and Apatinib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carilizumab and ApatinibDrug
Also called PD-1 antibody
After every 2 cycles of meparticipants. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical participants will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody Carilizumab combined with apatinib for unresectable dMMR gastric cancer | Experimental | Participants will receive Carilizumab 200mg repeated every 21 days and Apatinib 250mg everyday Receives: Drug: Carilizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 1-year PFS
The progression free survival (PFS) was defined as the time from the beginning of systematic anti-cancer therapy to disease progression or death from any cause
Measured: From enrollment to the end of treatment at 1year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start20 Apr 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baoshan Cao, Principal investigator, Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792162
- Sponsor's protocol ID
- IRB00006761-M2022295
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets analyzed during the study are available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Phase II Clinical Study of PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer
- ClinicalTrials.gov ID
- NCT06792162
- Acronym / sponsor ID
- IRB00006761-M2022295
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Jan 2025 (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.
Evaluate the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
Detailed description
This study is a prospective, open label, single center, phase II clinical trial aimed at evaluating the safety and efficacy of PD-1 antibody Carilizumab combined with apatinib for the conversion therapy of unresectable stage III and IV dMMR gastric cancer.
The study participants were unresectable stage III and IV dMMR gastric cancer patients who had not undergone any anti-tumor treatment. The study aims to enroll 20 participants with a primary endpoint of 1-year disease progression free survival rate. participants who meet the inclusion criteria will receive treatment with both Carilizumab and Apatinib, repeated every 21 days. During the conversion therapy period, the researchers evaluate whether surgery can be performed after every 2 cycles of medication for the subjects. After evaluation by the researchers, the participants were deemed eligible for surgery. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical subjects will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years.
After the treatment is completed, a treatment end visit, a post treatment safety visit, and survival follow-up will be conducted. Participants who end the study due to non disease progression reasons will undergo imaging evaluation at the end of treatment (if no imaging evaluation has been received within 4 weeks before the end of treatment), and imaging evaluation will be conducted every 2 months after the end of treatment to assess the time of disease progression. After the completion of treatment, the participants will undergo a survival follow-up every 90 days to collect and record their survival status and subsequent anti-tumor treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody Carilizumab combined with apatinib for unresectable dMMR gastric cancer | Experimental | Drug: Carilizumab and ApatinibParticipants will receive Carilizumab 200mg repeated every 21 days and Apatinib 250mg everyday |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than or equal to 18 years old, gender not limited;
- Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric adenocarcinoma (GC) (excluding neuroendocrine tumors) or gastroesophageal junction adenocarcinoma (GEJ);
- Unresectable gastric cancer patients with potential for conversion therapy, defined as gastric cancer patients with single organ metastasis (such as liver metastasis, ovarian metastasis, lung metastasis), retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, localized peritoneal metastasis, invasion of surrounding organs, and other gastric cancer patients evaluated by researchers as feasible for conversion therapy;
- Without surgery, radiation therapy, or immunotherapy for the gastric cancer lesion or metastatic tumor.
- ECOG PS score 0-1 points;
Key exclusion criteria (13 listed)
- Other malignant tumors have been diagnosed within 5 years before the first use of the investigational drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma and/or effectively resected cervical carcinoma in situ and/or breast cancer and/or thyroid cancer and other malignant tumors that have achieved long-term survival;
- Suffering from any active autoimmune disease or history of autoimmune disease, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (except for patients with stable hormone levels after treatment); Subjects with childhood asthma who have been completely relieved and do not require any intervention or vitiligo in adulthood may be included, but those who require medical intervention with bronchodilators may not be included;
- People with congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with co infection of hepatitis B and hepatitis C;
- Within 14 days prior to the first use of the investigational drug, immunosuppressive drugs have been used, excluding nasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs);
- Vaccination with attenuated live vaccine within 4 weeks before the first administration or planned during the study period;
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 |
|---|---|---|
| Carilizumab and ApatinibAlso: PD-1 antibodyAfter every 2 cycles of meparticipants. Apatinib was discontinued for one cycle and an additional course of Carilizumab was administered in preparation for surgery. The time between the last dose and surgery was 3-6 weeks, with a maximum of 6 weeks. Both surgical and non-surgical participants will continue to receive treatment with the original regimen of Carilizumab combined with Apatinib after surgery until disease progression, recurrence, or death, for a maximum of 2 years. | Drug | PD-1 antibody Carilizumab combined with apatinib for unresectable dMMR gastric cancer |
Primary outcome
The rate of 1-year PFS
Time frame: From enrollment to the end of treatment at 1year"
The progression free survival (PFS) was defined as the time from the beginning of systematic anti-cancer therapy to disease progression or death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes. The datasets analyzed during the study are available on reasonable request.
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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.
Baoshan Cao principal investigator
Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carilizumab and Apatinib in people with Gastric Cancer, run by Peking University Third Hospital 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhong Yao (+86 010-82265857, snowdream246@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 1-year PFS (time frame: From enrollment to the end of treatment at 1year"). 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 24 Jan 2025.