Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric AdenocarcinomaNCT06349044
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 study testing Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Anti-PD-1 monoclonal antibody and Oxaliplatin and Capecitabine in people with Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma and Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma, Hepatocellular Carcinoma, Biliary Tract Carcinoma
- What is being tested?
- Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Anti-PD-1 monoclonal antibody and Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- ECOG score of 0-1;
- be able to accept the treatment regimen during the study;
- sign a written informed consent.
Who cannot join
- 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;
- a history of other malignant disease within the last five years;
- persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
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- Subjects 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 limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; and serum creatinine <1 times the upper limit of normal. times the upper limit of normal;
- 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 bleeding or perforation as determined by the investigator;
- persons with active bleeding or bleeding tendencies;
- women who are pregnant or breastfeeding;
- allergy to any of the study drug ingredients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhengjiang Cancer Hospital
Hangzhou, Zhejiang
Ji Zhu, 13501978674, zhuji@zjcc.org.cn
About this study
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
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
- Being tested
- 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
- Keywords
- radiotherapy, immunotherapy, L. rhamnosus M9
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 antibodyDrug
Sintilimab 200mg d1 iv q3w
Oxaliplatin and CapecitabineDrug
Oxaliplatin130mg/m2 d1 iv；Capecitabine1000mg/m2 d1-d14
Anti-VEGF 15mg/kgDrug
Bevacizumab 15mg/kg d1 iv q3w
Anti-VEGF 7.5mg/kgDrug
Bevacizumab 7.5mg/kg d1 iv q3w
Gemcitabine and CisplatinDrug
Gemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w
| Study group | Role | What they receive |
|---|---|---|
| ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma | Experimental | patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Oxaliplatin and Capecitabine |
| ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma | Placebo comparator | patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Oxaliplatin and Capecitabine |
| ARM B: Liver adenocarcinoma | Experimental | patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Anti-VEGF 15mg/kg |
| ARM B*: Liver adenocarcinoma | Placebo comparator | patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Anti-VEGF 15mg/kg |
| ARM C: Malignant tumors of the biliary system | Experimental | patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Gemcitabine and Cisplatin |
| ARM C*: Malignant tumors of the biliary system | Placebo comparator | patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Gemcitabine and Cisplatin |
| ARM D:Colorectal cancer | Experimental | patients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Oxaliplatin and Capecitabine; Drug: Anti-VEGF 7.5mg/kg |
| ARM D*:Colorectal cancer | Placebo comparator | patients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy Receives: Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）; Drug: Anti-PD-1 monoclonal antibody; Drug: Oxaliplatin and Capecitabine; Drug: Anti-VEGF 7.5mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
for off-target lesions of radiotherapy
Measured: ORR will be assessed 2 months after radiotherapy
Secondary outcomes (6)
ORR
irradiated lesion
Measured: ORR will be assessed 2 months after radiotherapy
adverse effects rate
CTC 4.0
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years ]
Qol
EORTC-C30
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years]
PFS
Rate of 3 year disease free survival
Measured: From the date of randomization to the date when progress was first recorded,assessed up to 36 months.
OS
Rate of 3 year overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 36 months
Qol
EQ-5D
Measured: From date of randomization until the date of death from any cause, assessed up to 10 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start20 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349044
- Sponsor's protocol ID
- BASIMA
- Status last verified
- Aug 2024
- First submitted
- 21 Mar 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- BASIMA
- Conditions
- Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma, Hepatocellular Carcinoma, Biliary Tract Carcinoma, Colorectal Adenocarcinoma
- Keywords
- radiotherapy, immunotherapy, L. rhamnosus M9
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma | Experimental | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Oxaliplatin and Capecitabinepatients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma | Placebo comparator | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Oxaliplatin and Capecitabinepatients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM B: Liver adenocarcinoma | Experimental | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Anti-VEGF 15mg/kgpatients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM B*: Liver adenocarcinoma | Placebo comparator | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Anti-VEGF 15mg/kgpatients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM C: Malignant tumors of the biliary system | Experimental | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Gemcitabine and Cisplatinpatients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM C*: Malignant tumors of the biliary system | Placebo comparator | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Gemcitabine and Cisplatinpatients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM D:Colorectal cancer | Experimental | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Oxaliplatin and Capecitabine, Drug: Anti-VEGF 7.5mg/kgpatients will receive Probio-M9 ,RT followed by Immunotherapy-Based Systemic Therapy |
| ARM D*:Colorectal cancer | Placebo comparator | Radiation: Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Drug: Anti-PD-1 monoclonal antibody, Drug: Oxaliplatin and Capecitabine, Drug: Anti-VEGF 7.5mg/kgpatients will receive placebo ,RT followed by Immunotherapy-Based Systemic Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- ECOG score of 0-1;
Key exclusion criteria (11 listed)
- 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;
- a history of other malignant disease within the last five years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM B*: Liver adenocarcinoma, ARM B: Liver adenocarcinoma, ARM C*: Malignant tumors of the biliary system, ARM C: Malignant tumors of the biliary system, ARM D*:Colorectal cancer, ARM D:Colorectal cancer |
| Anti-PD-1 monoclonal antibodySintilimab 200mg d1 iv q3w | Drug | ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM B*: Liver adenocarcinoma, ARM B: Liver adenocarcinoma, ARM C*: Malignant tumors of the biliary system, ARM C: Malignant tumors of the biliary system, ARM D*:Colorectal cancer, ARM D:Colorectal cancer |
| Oxaliplatin and CapecitabineOxaliplatin130mg/m2 d1 iv；Capecitabine1000mg/m2 d1-d14 | Drug | ARM A*:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM A:Her-2 negative adenocarcinoma of the gastroesophageal junction/gastric adenocarcinoma, ARM D*:Colorectal cancer, ARM D:Colorectal cancer |
| Anti-VEGF 15mg/kgBevacizumab 15mg/kg d1 iv q3w | Drug | ARM B*: Liver adenocarcinoma, ARM B: Liver adenocarcinoma |
| Anti-VEGF 7.5mg/kgBevacizumab 7.5mg/kg d1 iv q3w | Drug | ARM D*:Colorectal cancer, ARM D:Colorectal cancer |
| Gemcitabine and CisplatinGemcitabine1000mg/m2 d1 d8 iv；Cisplatin 25mg/m2 d1 d8 iv q3w | Drug | ARM C*: Malignant tumors of the biliary system, ARM C: Malignant tumors of the biliary system |
Primary outcome
ORR
Time frame: ORR will be assessed 2 months after radiotherapy
for off-target lesions of radiotherapy
6 secondary outcomes
ORR
Time frame: ORR will be assessed 2 months after radiotherapy
adverse effects rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years ]
Qol
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years]
PFS
Time frame: From the date of randomization to the date when progress was first recorded,assessed up to 36 months.
OS
Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months
Qol
Time frame: From date of randomization until the date of death from any cause, assessed up to 10 years]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated radiotherapy/SBRT（5-10Gy/fx，3-5 fx）, Anti-PD-1 monoclonal antibody and Oxaliplatin and Capecitabine in people with Her-2 Negative Adenocarcinoma of the Gastro-oesophageal Junction/Gastric Adenocarcinoma and Hepatocellular Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhu ji (13501978674, zhuji@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: ORR will be assessed 2 months after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.