Combining Sintilimab with FOLFIRI for Advanced Gastric Cancer Treatment

Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer: a Prospective Single-arm Phase II Study

This study is testing if combining a new immune therapy called sintilimab with a chemotherapy treatment can help people with advanced stomach cancer who haven't responded to their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: sintilimab, chemotherapy, immunotherapy, radiation, prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06365008 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the effectiveness of sintilimab, an immune checkpoint inhibitor, combined with the chemotherapy regimen FOLFIRI (irinotecan, leucovorin, and fluorouracil) as a salvage therapy for patients with unresectable or metastatic gastric cancer who have progressed after first-line treatment. The study is open-label and conducted at a single center, focusing on patients aged 18-75 with specific eligibility criteria related to their cancer progression and overall health. Participants will receive a tailored dosage of sintilimab and the FOLFIRI regimen to assess the treatment's efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with unresectable or metastatic gastric adenocarcinoma who have experienced progression or intolerable toxicity from first-line treatment.

Not a fit: Patients with resectable gastric cancer or those who have not progressed after first-line therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastric cancer who have limited treatment choices after first-line therapy.

How similar studies have performed: While the combination of immune checkpoint inhibitors and chemotherapy has shown promise in other studies, this specific approach is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Metastatic or locally advanced, unresectable gastric adenocarcinoma confirmed by histology or cytology
2. Progression or toxicity intolerance of first-line treatment
3. Age 18-75 years old
4. ECOG score 0-2
5. Estimated life expectancy of at least 12 weeks
6. Adequate organ and bone marrow function, as follows: Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL,Total bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase, aspartate aminotransferase (AST (SGOT) and alanine aminotransferase (ALT (SGPT)) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum albumin≥2.8g/dl, Serum creatinine ≤1.5 x ULN or calculated creatinine clearance \>50mL/min (calculated according to Cockcroft Gault formula)
7. International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) \<1.5 x ULN (thromboembolic event must be ruled out if D-dimer is abnormal)
8. Negative pregnancy test not more than 7 days before enrollment,Pregnancy tests can only be omitted in women who do not have any reproductive potential (e.g., postmenopausal women, i.e. amenorrhea ≥2 years or prior hysterectomy or bilateral oophorectomy). Fertile women and men must consent to the use of appropriate contraception at the time of enrollment and during study participation for at least 3 months after the last treatment
9. Have sufficient understanding ability and be willing to sign written informed consent

Exclusion Criteria:

1. Pregnant and lactating women
2. The patient has experienced hyperprogression and immunotherapy related grade 3 or above adverse reactions during previous immunotherapy
3. Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug, the total area of previous bone marrow radiation therapy exceeds 30%; the exception is that if it is not the target lesion, palliative radiotherapy is allowed, and the radiotherapy area must be less than 25% of the bone marrow area
4. Suffering from other malignant tumors within the past 5 years or simultaneously
5. Suffering from severe neurological and psychiatric disorders
6. Patients with uncontrolled or symptomatic brain metastases
7. Patients with active autoimmune diseases
8. Immunosuppressive or systemic hormone therapy for immunosuppressive purposes (dose \>10mg/ day prednisone or other therapeutic hormone) within 14 days prior to initiation of study therapy
9. Allergies to investigational drugs or excipients
10. Hypertension that cannot be controlled by antihypertensive drugs, coronary heart disease, heart failure, and arrhythmia (QTcF prolongation,\>450ms in males and\>470ms in females)
11. Severe infection in the 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumoniaOral or intravenous administration of therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, for example, to prevent urinary tract infections or exacerbation of chronic obstructive pulmonary disease are eligible for study participation)
12. Patients with congenital or acquired immune deficiency (such as HIV infection)
13. Have received live attenuated vaccines within 28 days prior to initiation of study treatment, or are expected to require such vaccines during sintilimab treatment or within 60 days after the last administration of sintilimab

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Qiong Yang, Doctor — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Qiong Yang, Doctor

Conditions Unresectable/Metastatic Gastric Cancer; Sintilimab; FOLFIRI; salvage therapy