Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy

NCT07309185 | Recruiting Phase 2

• 1 other identifier: MA-GC-II-018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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,

Conditions

Stomach Neoplasms

Keywords

Immune checkpoint inhibitors; Adebrelimab Injection; Famitinib; Second line treatment for advanced

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  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

  The longest follow-up period from the patient's enrollment to death from any cause is 2 years

• DCR

  The longest follow-up period from enrollment to the first efficacy evaluation is 3 months

• safety：Record the incidence rate of all adverse events

  From enrollment until 90 days after the last dose of medication

Study Arms (2)

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.

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.

Drug: Irinotecan

Interventions

Adebrelimab DRUG

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.

Group 1

Irinotecan DRUG

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 1; Group 2

Malic acid Famitinib DRUG

Malic acid Famitinib: 20mg, po, d1-21.

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;
• \. 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;
• \. 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);
• \. ECOG score: 0-1 point;
• \. Expected survival period ≥ 12 weeks;
• \. 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);
• \. 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;
• \. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• \. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
• \. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
• \. History of allergies to any component of Adebrelimab in the past;
• \. 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;
• 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;
• \. Patients with active central nervous system metastases;
• \. 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;
• \. 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);
• \. 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;

Sponsors & Collaborators

• Shandong Tumor Hospital: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Bo Liu, Professor

  Shandong First Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Liu, Prof.

CONTACT

+86 15553115688; 15553115688@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 30, 2025
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)