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.

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.

Trial Details

NCT ID
NCT06349044
Phase
NA
Sponsor
Zhejiang Cancer Hospital
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）
  • Anti-PD-1 monoclonal antibody
  • Oxaliplatin and Capecitabine
  • Anti-VEGF 15mg/kg
  • Anti-VEGF 7.5mg/kg
  • Gemcitabine and Cisplatin
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroeso…
  • advanced patients evaluated as initially non-operable resectable who have not received any antitumor therapy;
  • have at least one measurable or evaluable lesion according to RECIST v1.1 criteria in addition to the primary lesion, with non-operable resectable …
  • age 18-75 years;

For full eligibility, visit ClinicalTrials.gov.

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