Trials / Recruiting
RecruitingNCT06349044
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.
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Zhejiang Cancer Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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
- Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma
- Hepatocellular Carcinoma
- Biliary Tract Carcinoma
- Colorectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx） | RT: one primary or metastatic focus was selected for hypofractionated radiotherapy/SBRT (5-10 Gy/fx, 3-5 fx) in each round, the target area included only the GTV of the visible tumor lesion, and the GTV was expanded by 5-10 mm to generate the PTV, and the prophylactic lymphatic drainage area could not be irradiated. |
| DRUG | Anti-PD-1 monoclonal antibody | Sintilimab 200mg d1 iv q3w |
| DRUG | Oxaliplatin and Capecitabine | Oxaliplatin130mg/m2 d1 iv；Capecitabine1000mg/m2 d1-d14 |
| DRUG | Anti-VEGF 15mg/kg | Bevacizumab 15mg/kg d1 iv q3w |
| DRUG | Anti-VEGF 7.5mg/kg | Bevacizumab 7.5mg/kg d1 iv q3w |
| DRUG | Gemcitabine and Cisplatin | Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w |
Timeline
- Start date
- 2024-03-20
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2024-04-05
- Last updated
- 2024-08-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06349044. Inclusion in this directory is not an endorsement.