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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.

NCT06349044 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06349044 on ClinicalTrials.gov