Actively Recruiting
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.
Led by Zhejiang Cancer Hospital · Updated on 2024-08-27
120
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on the interaction between radiation therapy and immunotherapy and the potential potentiation of Probio-M9 for the treatment of ICIs, this study is planned to design an integrated treatment protocol for the first-line treatment of advanced gastrointestinal tumors through the use of macrofractionated radiotherapy as a means of immune activation, combined with the synergistic effect of Probio-M9 microbial agents and PD-1 inhibitors.
CONDITIONS
Official 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 advanced gastrointestinal malignant tumors (including Her-2 negative gastroesophageal junction/gastric adenocarcinoma, hepatocellular carcinoma, biliary tract carcinoma, colorectal cancer)
- Initially non-operable resectable advanced patients with no prior antitumor therapy
- At least one measurable or evaluable lesion besides the primary tumor with non-operable resectable lymph node metastases (except brain metastases)
- Age between 18 and 75 years
- ECOG performance status score of 0 to 1
- Able to accept the study treatment regimen
- Signed written informed consent
You will not qualify if you...
- History of uncontrolled epilepsy, severe central nervous system disease, or psychiatric disorder affecting consent or medication adherence
- Prior immunotherapy or severe allergic reactions to monoclonal antibodies
- Active significant cardiac disease or recent myocardial infarction within 12 months
- Organ transplantation requiring immunosuppressive therapy
- Other malignant diseases within the last five years
- Severe uncontrolled infections or other severe uncontrolled diseases
- Abnormal baseline blood counts or biochemistry outside specified limits
- Active gastrointestinal diseases causing bleeding or risk of perforation
- Active bleeding or bleeding disorders
- 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
Trial Site Locations
Total: 1 location
1
Zhengjiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
zhu ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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