Gastric cancer
Conditions
Interventions
Trial Group:Sintilimab combined therapy (referencing historical control as paclitaxel combination regimen)
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical study; full understanding and informed consent to the study, with signed Informed Consent Form (ICF); willingness and ability to comply with and complete all study procedures. 2. No gender restriction; age >= 18 years at the time of signing the ICF. 3. Histologically confirmed adenocarcinoma of the stomach and gastroesophageal junction (GEJ), including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma, etc., with negative HER-2 status. 4. Previous D2 radical gastrectomy with R0 resection, followed by adjuvant therapy with an oxaliplatin-plus-fluoropyrimidine regimen. 5. Recurrence during adjuvant therapy or within 6 months after completion of adjuvant therapy, with evaluable lesions. 6. ECOG performance status (PS) 0–2 within 7 days prior to the first study treatment. 7. Expected survival >= 3 months. 8. Adequate major organ function, defined as meeting the following laboratory and examination requirements within 14 days prior to enrollment: (1) Hemoglobin >= 80 g/L; (2) Absolute neutrophil count > 1.5 × 10^9/L; (3) Platelet count >= 80 × 10^9/L; (4) Total bilirubin = 60 mL/min (calculated by the Cockcroft-Gault formula); (7) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; (8) Thyroid function parameters: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4) within normal limits, or only mildly abnormal without associated clinical symptoms; Body weight >= 40 kg (inclusive), or body mass index (BMI) > 18.5. 9. Availability of representative tumor tissue samples, blood samples, and stool samples for exploratory research.
Exclusion criteria
Exclusion criteria: 1. Active malignancy within the past 5 years or concurrent active malignancy. Patients with cured localized tumors (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast) may be enrolled. 2. Participation in another investigational drug clinical trial within 4 weeks prior to initiation of study treatment. 3. Presence of central nervous system (CNS) disorders or symptomatic CNS metastases. 4. Patients planning to undergo or who have previously received organ or bone marrow transplantation. 5. History or evidence of thrombotic or hemorrhagic disease within 6 months prior to the first study treatment. 6. Active pulmonary tuberculosis. 7. Previous or current interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, severe pulmonary dysfunction, or other conditions that may interfere with the detection or management of suspected drug-related pulmonary toxicity. 8. Uncontrolled hypertension (SBP >= 150 mmHg and/or DBP >= 100 mmHg), history of hypertensive crisis, or cardiovascular disease (congestive heart failure >= Grade II or worse, myocardial ischemia, unstable angina, stroke, or transient ischemic attack). 9. Patients at high risk of gastrointestinal perforation (history of gastrointestinal fistula, perforation, intra-abdominal abscess, partial or complete small bowel obstruction, or requirement for total parenteral nutrition). 10. Moderate to severe proteinuria. 11. Presence of non-healing wounds, ulcers, or fractures. 12. Known active or suspected autoimmune disease, except patients with stable disease at enrollment (not requiring systemic immunosuppressive therapy). 13. Known severe hypersensitivity to any monoclonal antibody or its excipients. 14. Known history of psychoactive substance abuse or drug addiction; patients who have stopped alcohol consumption may be enrolled. 15. Patients with any other severe acute or chronic medical condition that may increase the risk associated with study medication, or who are deemed ineligible for participation in the clinical study by the investigator. 16. Previously exposed to VEGF (vascular endothelial growth factor) or VEGFR inhibitors or any anti-angiogenic drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Safety Outcomes (including Adverse Events, ECOG Performance Status, Physical Examination, Laboratory Changes [Hematology, Biochemistry, Coagulation, Thyroid Function, Urinalysis, Serum Pregnancy Test], Vital Signs Changes [Blood Pressure, Heart Rate, Respiratory Rate, Temperature], 12-Lead Electrocardiogram, Echocardiography, Treatment-Related Adverse Events [TRAE], Grade =3 TRAE, Incidence and Severity of Immune-Related Adverse Events [irAE]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactWu Hao
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed