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New treatment option for Tislelizumab
Official title XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC
ClinicalTrials.gov ID: NCT05970302
What this study is testing
What is Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine?
Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine is an investigational medicine, being studied as a potential treatment for tislelizumab.
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
- The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma;
- ECOG score of 0 or 1;
- Ability to swallow oral medications;
- Have at least one measurable lesion (according to RECIST v1.1 standard);
- No anti-tumor treatment has been received after recurrence and metastasis;
You likely can't join if
- Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antibodies or pathway-targeted drugs;
- Received radiotherapy within 4 weeks before the evaluation;
- Symptomatic peripheral neuropathy \> grade 2 (CTCAE5.0 standard);
- Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;
- HIV-positive and other immunodeficiency diseases;
- Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen...
See the full eligibility criteria
- Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma;
- ECOG score of 0 or 1;
- Ability to swallow oral medications;
- Have at least one measurable lesion (according to RECIST v1.1 standard);
- No anti-tumor treatment has been received after recurrence and metastasis;
- Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in...
- Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5\ 10\^9/L and neutrophils ≥ 1.5\ 10\^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100\ 10\^9/L; serum bilirubin ≤...
- Expected survival period ≥ 3 months;
- Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;
- Women with reproductive potential (\< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.
- Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antibodies or pathway-targeted drugs;
- Received radiotherapy within 4 weeks before the evaluation;
- Symptomatic peripheral neuropathy \> grade 2 (CTCAE5.0 standard);
- Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;
- HIV-positive and other immunodeficiency diseases;
- Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA...
- Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not...
- Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily...
- Have a history of organ transplantation;
- Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;
- Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or...
- Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors...
- Combined active and refractory infection;
- Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of...
- Evidence of causing coagulation disease;
- With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as...
- Severe unhealed wounds/ulcers or severe fractures;
- Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;
- There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;
- Pregnant or lactating women;
- No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg/day allowed);
- Severe allergic reaction to the test drug;
- Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.