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New treatment option for Her-2 Negative Adenocarcinoma of the Gastro-oesophageal...
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.
ClinicalTrials.gov ID: NCT06349044
What this study is testing
What is Anti-PD-1 monoclonal antibody?
Anti-PD-1 monoclonal antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her-2 negative adenocarcinoma of the gastro-oesophageal junction/gastric adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the...
- 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;
- ECOG score of 0-1;
You likely can't join if
- a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder of clinical severity that, in the judgment of the...
- 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...
- organ transplantation requiring immunosuppressive therapy;
- a history of other malignant disease within the last five years;
- persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
See the full eligibility criteria
- histopathologically confirmed diagnosis of malignant tumors of the gastrointestinal tract (including Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, hepatocellular carcinoma...
- 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...
- age 18-75 years;
- ECOG score of 0-1;
- be able to accept the treatment regimen during the study;
- sign a written informed consent.
- 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...
- 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...
- organ transplantation requiring immunosuppressive therapy;
- a history of other malignant disease within the last five years;
- persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- people whose baseline blood routine and biochemical indexes do not meet the following criteria: hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper...
- the patient currently has active gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal...
- persons with active bleeding or bleeding tendencies;
- women who are pregnant or breastfeeding;
- allergy to any of the study drug ingredients.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.