Status:
NOT_YET_RECRUITING
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Immunotherapy
Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study plans to enroll 156 patients aged 18-75, who will be randomly divided into two groups to evaluate the clinical efficacy and safety of chemotherapy and immune therapy combined with Lactobaci...
Detailed Description
Research Objective This study is a randomized, double-blind, controlled, prospective multicenter clinical trial, designed to evaluate the clinical efficacy and safety of chemotherapy and immune therap...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Age 18-75 years.
- Histologically confirmed unresectable/metastatic tumors:
- EGFR/ALK wild-type adenocarcinoma non-small cell lung cancer (NSCLC) PD-L1+ (CPS≥1) triple-negative breast cancer (TNBC) HER2- gastric/gastroesophageal adenocarcinoma
- ≥1 measurable lesion (RECIST v1.1).
- Progression after PD-1/PD-L1 inhibitor therapy (defined as:
- ≥2 doses administred.
- Radiographic progression per RECIST/iRECIST/irRECIST, confirmed ≥4 weeks later.
- Progression within 12 weeks of last PD-1/PD-L1 dose.
- Adequate organ function.
- ECOG performance status 0-1.
- Negative pregnancy test (urine/serum β-HCG) for women of childbearing potential.
Exclusion
- 1\. Prior allogeneic transplantation (cells, tissues, or solid organs). 2. History of immune-related adverse events (irAEs) from immunomodulators (e.g., PD-1/PD-L1 or CTLA-4 inhibitors) leading to permanent discontinuation or Grade 3/4 severity.
- 3\. Recent anticancer therapy (chemotherapy/immunotherapy/biologics/experimental drugs) within: \<5 half-lives of the drug or \<21 days before starting study treatment (whichever is shorter). Exceptions: Stable hormone therapy (e.g., for prostate/breast/ovarian cancer).
- 4\. Concomitant corticosteroid use (\>10 mg prednisone/day or equivalent) within 7 days prior to treatment, unless for physiological replacement (≤10 mg/day) or non-immunosuppressive purposes (e.g., inhaled/topical steroids).
- 5\. Severe cardiac dysfunction, including: NYHA Class III-IV heart failure, symptomatic coronary artery disease, severe ventricular arrhythmias, myocardial infarction/unstable angina within 6 months.
- 6\. Active autoimmune disease requiring systemic treatment (immunosuppressants/corticosteroids) in the past 2 years, except: Hormone replacement (thyroxine, insulin, physiologic corticosteroids).
- 7\. Active severe infection requiring systemic therapy. 8. Antibiotic use completed within 2 weeks before the first dose. 9. Psychiatric or substance abuse disorders compromising protocol compliance. 10. Live vaccines administered within 28 days before treatment. 11. Active HIV or hepatitis (A/B/C) infection. 12. History of steroid-requiring (non-infectious) pneumonitis or current active pneumonitis.
- 13\. Other malignancies requiring active treatment or progressing within 2 years (exceptions: Non-melanoma skin cancer, cervical/prostate carcinoma in situ).
- 14\. Pregnancy or lactation. 15. Known intolerance/allergy to study drugs. 16. Other conditions deemed unsuitable by investigators.
Key Trial Info
Start Date :
September 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT07191405
Start Date
September 18 2025
End Date
December 31 2026
Last Update
September 24 2025
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