Health TrialsbyHealthPanel

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.

ConditionsHer-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric AdenocarcinomaHepatocellular CarcinomaBiliary Tract CarcinomaColorectal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, colorectal cancer);

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 lymph node metastases to the liver, lung, bone, pelvis, retroperitoneum and/or superficial sites (except for brain metastases), as evaluated by discussion in the framework of the MDT

age 18-75 years;

Disqualifiers

a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the investigator, may preclude the signing of an informed consent form or interfere with the patient's adherence to oral medication;

prior immunotherapy for any indication or a history of severe hypersensitivity reactions to other monoclonal antibodies;

clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months;

organ transplantation requiring immunosuppressive therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）

    Radiation

    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.

  • Anti-PD-1 monoclonal antibody

    Drug

    Sintilimab 200mg d1 iv q3w

  • Oxaliplatin and Capecitabine

    Drug

    Oxaliplatin130mg/m2 d1 iv；Capecitabine1000mg/m2 d1-d14

  • Anti-VEGF 15mg/kg

    Drug

    Bevacizumab 15mg/kg d1 iv q3w

  • Anti-VEGF 7.5mg/kg

    Drug

    Bevacizumab 7.5mg/kg d1 iv q3w

  • Gemcitabine and Cisplatin

    Drug

    Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w

Treatment groups

120 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinomaExperimental treatment 3 interventions
Group B: ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinomaPlacebo comparator 3 interventions
Group C: ARM B: Liver adenocarcinomaExperimental treatment 3 interventions
Group D: ARM B*: Liver adenocarcinomaPlacebo comparator 3 interventions
Group E: ARM C: Malignant tumors of the biliary systemExperimental treatment 3 interventions
Group F: ARM C*: Malignant tumors of the biliary systemPlacebo comparator 3 interventions
Group G: ARM D:Colorectal cancerExperimental treatment 4 interventions
Group H: ARM D*:Colorectal cancerPlacebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

ORR

for off-target lesions of radiotherapy

Time frame
ORR will be assessed 2 months after radiotherapy

Secondary outcomes

1

ORR

irradiated lesion

Time frame
ORR will be assessed 2 months after radiotherapy
2

adverse effects rate

CTC 4.0

Time frame
From date of randomization until the date of death from any cause, assessed up to 5 years ]
3

Qol

EORTC-C30

Time frame
From date of randomization until the date of death from any cause, assessed up to 10 years]
4

PFS

Rate of 3 year disease free survival

Time frame
From the date of randomization to the date when progress was first recorded,assessed up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now