Stomach NeoplasmsPhase 2NCT07309185
Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy
A Phase 2 study testing Adebrelimab, Irinotecan and Malic acid Famitinib in people with Stomach Neoplasms, run by Shandong Tumor Hospital at 1 site in China.
Trial summary
This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer, Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Adebrelimab, Irinotecan and Malic acid Famitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 31 Jul 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- 2. Patients who have previously failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, and have maintained first-line use of immune checkpoint inhibitors for at least 3 months;
- 3. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
- 4. ECOG score: 0-1 point;
- 5. Expected survival period ≥ 12 weeks;
- 6. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula);
- 7. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period, at least 6 months after the last use of Adebrelimab, and at least 6 months after the last use of chemotherapy;
- 8. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- 1. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- 2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- 3. History of allergies to any component of Adebrelimab in the past;
- 4. Have received any of the following treatments:
- Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;
- Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;
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- Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;
- Subjects who need to receive corticosteroids (equivalent to>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Allow the use of hormones for routine chemotherapy pretreatment without the need for dose adjustment. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;
- Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;
- Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;
- Patients who have received previous treatment with paclitaxel drugs;
- 5. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/exclusion criteria;
- 6. Patients with active central nervous system metastases;
- 7. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
- 8. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);
- 9. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
- 10. Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;
- 11. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
- 12. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
- 13. Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;
- 14. Pregnant or lactating women;
- 15. According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.
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
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong
Bo Liu, Prof., +86 15553115688
About this study
Official title: Adebrelimab Combined With Famitinib Malate and Irinotecan Versus Irinotecan in Patients With Advanced Gastric Cancer After Failure of First-Line Therapy: A Randomized, Controlled, Exploratory Clinical Study
This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,
Read the detailed description
Among these, 6 cases were in the safety run-in period, receiving treatment with Adeberlimab combined with Famitinib and Irinotecan. The safety during the first 3 months of medication was observed to determine whether DLT (Dose-Limiting Toxicity) occurred within the treatment cycle. If ≤ 2 subjects experienced DLT, the study would proceed to the extension treatment phase; if > 2 subjects experienced DLT, the study would be terminated.
DLT is defined as the occurrence of any of the following drug-related events during the first treatment cycle: grade 4 hematologic toxicity; grade 3 neutropenia with fever; grade 3 thrombocytopenia with bleeding; or any other grade 3 non-hematologic toxicity (excluding alopecia).
After the safety importation period, patients will enter the extended treatment phase, with an additional 60 cases to be enrolled and randomly assigned in a 1:1 ratio to either the experimental group or the control group.
The experimental group received treatment with Adeberlimab combined with famitinib maleate and irinotecan until disease progression, intolerable adverse reactions, or death.
The control group received irinotecan treatment until disease progression, unacceptable toxicity, or death.
- Conditions
- Stomach Neoplasms
- Being tested
- Adebrelimab, Irinotecan, Malic acid Famitinib
- Keywords
- Immune checkpoint inhibitors, Adebrelimab Injection, Famitinib, Second line treatment for advanced
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab Injection: 1200mg, i.v.gtt, d1,
Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
IrinotecanDrug
Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
Malic acid FamitinibDrug
Malic acid Famitinib: 20mg, po, d1-21.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Adebrelimab Injection: 1200mg, i.v.gtt, d1, Malic acid Famitinib: 20mg, po, d1-21. Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. Receives: Drug: Adebrelimab; Drug: Irinotecan; Drug: Malic acid Famitinib |
| Group 2 | Active comparator | Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years
Secondary outcomes (3)
mOS
median survival time
Measured: The longest follow-up period from the patient's enrollment to death from any cause is 2 years
DCR
Disease Control Rate
Measured: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months
safety：Record the incidence rate of all adverse events
Record the incidence rate of all adverse events
Measured: From enrollment until 90 days after the last dose of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start24 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuping Ding, Shandong Tumor Hospital
- Investigators
- Bo Liu, Professor, Principal investigator, Shandong First Medical University Affiliated Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309185
- Sponsor's protocol ID
- MA-GC-II-018
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Combined With Famitinib Malate and Irinotecan Versus Irinotecan in Patients With Advanced Gastric Cancer After Failure of First-Line Therapy: A Randomized, Controlled, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT07309185
- Acronym / sponsor ID
- MA-GC-II-018
- Conditions
- Stomach Neoplasms
- Keywords
- Immune checkpoint inhibitors, Adebrelimab Injection, Famitinib, Second line treatment for advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shandong Tumor HospitalUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 30 Dec 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.
This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,
Detailed description
Among these, 6 cases were in the safety run-in period, receiving treatment with Adeberlimab combined with Famitinib and Irinotecan. The safety during the first 3 months of medication was observed to determine whether DLT (Dose-Limiting Toxicity) occurred within the treatment cycle. If ≤ 2 subjects experienced DLT, the study would proceed to the extension treatment phase; if > 2 subjects experienced DLT, the study would be terminated.
DLT is defined as the occurrence of any of the following drug-related events during the first treatment cycle: grade 4 hematologic toxicity; grade 3 neutropenia with fever; grade 3 thrombocytopenia with bleeding; or any other grade 3 non-hematologic toxicity (excluding alopecia).
After the safety importation period, patients will enter the extended treatment phase, with an additional 60 cases to be enrolled and randomly assigned in a 1:1 ratio to either the experimental group or the control group.
The experimental group received treatment with Adeberlimab combined with famitinib maleate and irinotecan until disease progression, intolerable adverse reactions, or death.
The control group received irinotecan treatment until disease progression, unacceptable toxicity, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Adebrelimab, Drug: Irinotecan, Drug: Malic acid FamitinibAdebrelimab Injection: 1200mg, i.v.gtt, d1, Malic acid Famitinib: 20mg, po, d1-21. Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. |
| Group 2 | Active comparator | Drug: IrinotecanIrinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
- 2. Patients who have previously failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, and have maintained first-line use of immune checkpoint inhibitors for at least 3 months;
- 3. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);
- 4. ECOG score: 0-1 point;
- 5. Expected survival period ≥ 12 weeks;
Key exclusion criteria (22 listed)
- 1. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
- 2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
- 3. History of allergies to any component of Adebrelimab in the past;
- 4. Have received any of the following treatments:
- 5. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/exclusion criteria;
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 |
|---|---|---|
| AdebrelimabAdebrelimab Injection: 1200mg, i.v.gtt, d1, Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. | Drug | Group 1 |
| IrinotecanIrinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years. | Drug | Group 1, Group 2 |
| Malic acid FamitinibMalic acid Famitinib: 20mg, po, d1-21. | Drug | Group 1 |
Primary outcome
PFS
Time frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years
Progression free survival
3 secondary outcomes
mOS
Time frame: The longest follow-up period from the patient's enrollment to death from any cause is 2 years
DCR
Time frame: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months
safety：Record the incidence rate of all adverse events
Time frame: From enrollment until 90 days after the last dose of medication
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 30 Dec 2025.
- 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.
Bo Liu, Professor principal investigator
Shandong First Medical University Affiliated Cancer 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 Adebrelimab, Irinotecan and Malic acid Famitinib in people with Stomach Neoplasms, run by Shandong Tumor 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 8 inclusion and 22 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 30 Dec 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 Bo Liu, Prof. (+86 15553115688, 15553115688@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years). 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 30 Dec 2025.