Actively Recruiting
Randomized Phase II Study of Hypofractionated Radiotherapy Followed by Immunotherapy With or Without L. Rhamnosus M9 for Advanced Digestive System Cancers
Led by Zhejiang Cancer Hospital · Updated on 2024-08-27
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined treatment approach for advanced gastrointestinal tumors, focusing on the interaction between radiation therapy and immunotherapy. The study aims to design a first-line treatment protocol using macrofractionated radiotherapy to activate the immune system, along with the potential synergistic effects of the Probio-M9 microbial agent and PD-1 inhibitors. This randomized, multicenter phase II basket study includes patients with various advanced digestive system malignancies such as gastric adenocarcinoma, hepatocellular carcinoma, biliary tract carcinoma, and colorectal adenocarcinoma. Participants are assigned to receive either Probio-M9 with hypofractionated radiotherapy or a placebo with radiotherapy, followed by immunotherapy-based systemic treatments. The radiotherapy involves targeting one primary or metastatic tumor focus with doses of 5-10 Gy per fraction over 3-5 fractions. Immunotherapy includes administration of anti-PD-1 monoclonal antibodies and chemotherapy agents such as oxaliplatin, capecitabine, bevacizumab, gemcitabine, and cisplatin, depending on the cancer type. The study groups correspond to specific tumor types and compare the effects of adding Probio-M9 to standard treatment. During the study, participants will be monitored through assessments of tumor response using the objective response rate (ORR) at two months after radiotherapy. Additional evaluations include adverse effects, quality of life, progression-free survival, and overall survival with follow-ups lasting up to 10 years. Safety and treatment adherence will be closely observed. The total participation timeline includes regular clinical visits and assessments to measure treatment outcomes and patient well-being.
CONDITIONS
Brief Title
A Randomized, Multicenter Phase II Basket Study of Hypofractionated Radiotherapy/Stereotactic Body Radiotherapy Followed by Immunotherapy-Based Systemic Therapy +/- L. Rhamnosus M9 for the First-Line Treatment of Advanced Digestive System Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract, including Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, hepatocellular carcinoma, malignant tumors of the biliary system, or colorectal cancer
- Advanced patients initially evaluated as non-operable resectable who have not received any antitumor therapy
- At least one measurable or evaluable lesion per RECIST v1.1 criteria, with non-operable resectable lymph node metastases excluding brain metastases
- Age between 18 and 75 years
- ECOG performance status of 0 or 1
- Able to accept the treatment regimen during the study
- Signed written informed consent
You will not qualify if you...
- History of uncontrolled epilepsy, central nervous system disease, or severe psychiatric disorder interfering with consent or adherence
- Prior immunotherapy or severe hypersensitivity to monoclonal antibodies
- Active cardiac disease including symptomatic coronary artery disease, NYHA class II or worse heart failure, severe arrhythmias needing treatment, or myocardial infarction within last 12 months
- Organ transplantation requiring immunosuppressive therapy
- History of other malignant disease within last five years
- Severe uncontrolled infections or other severe concomitant diseases
- Baseline blood and biochemical values outside specified limits (hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine)
- Active gastrointestinal diseases causing bleeding or risk of perforation
- Active bleeding or bleeding tendencies
- Pregnant or breastfeeding women
- Allergy to any study drug ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 treatment sessions over approximately 1 to 2 weeks
Participants receive hypofractionated radiotherapy targeting one primary or metastatic tumor lesion with 3 to 5 treatment sessions.
3 to 5 visits (in-person)
Duration - Ongoing treatment cycles every 3 weeks until disease progression or discontinuation
Participants receive immunotherapy with anti-PD-1 monoclonal antibody and chemotherapy regimens as part of systemic treatment following radiotherapy.
Visits every 3 weeks for treatment administration and assessments
Duration - Up to 10 years
Participants are monitored for treatment response, adverse effects, and quality of life for up to several years after treatment.
Periodic visits as scheduled for assessments
Trial Site Locations
Total: 1 location
1
Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
zhu ji
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here