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Tests treatment safety and results for Rectal Cancer
Official title Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement
ClinicalTrials.gov ID: NCT07104604
What this study is testing
What is Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy?
Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy is an investigational medicine, being studied as a potential treatment for rectal cancer.
Also referred to as New Neoadjuvant Treatment Approach.
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 evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1.
- 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 to 75
You may be able to join if
- Here is the updated format for the \ \ Eligibility Criteria\ \ with bullet points for each item:
- Age: 18-75 years, no gender restriction
- ECOG score 0-1
- Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)
- Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery
You likely can't join if
- Patients with a history of other malignancies within the past 5 years (except for cured and non-recurring cancers such as in situ carcinoma, basal...
- Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined by persistent signs/symptoms related...
- Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular...
- Patients known to be allergic or intolerant to the treatment drugs or excipients used in this study
- Any clinical indicators showing contraindications to chemotherapy and surgery
- Patients using strong inhibitors or inducers of enzymes such as CYP3A4, CYP2C8, and UGT1A1
See the full eligibility criteria
- Here is the updated format for the \ \ Eligibility Criteria\ \ with bullet points for each item:
- Age: 18-75 years, no gender restriction
- ECOG score 0-1
- Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)
- Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery
- Routine chest and abdominal CT scans showing no distant metastasis
- Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count (PLT) ≥ 100 × 10\^9/L, hemoglobin (Hb) ≥ 70 g/L
- Liver function: ALT, AST ≤ 2.5 × ULN (upper limit of normal); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL
- Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula)
- For females and patients with reproductive potential, a negative pregnancy test must be done within 72 hours before starting the treatment, and the patient must agree to avoid pregnancy during the study treatment and...
- Patients must agree to receive the study's neoadjuvant chemotherapy regimen and sign an informed consent form
- Patients with a history of other malignancies within the past 5 years (except for cured and non-recurring cancers such as in situ carcinoma, basal cell carcinoma of the skin, etc.)
- Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined by persistent signs/symptoms related to infection, which do not improve despite appropriate antibiotics...
- Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial disease, or other...
- Patients known to be allergic or intolerant to the treatment drugs or excipients used in this study
- Any clinical indicators showing contraindications to chemotherapy and surgery
- Patients using strong inhibitors or inducers of enzymes such as CYP3A4, CYP2C8, and UGT1A1
- Pregnant or breastfeeding women, and female patients of reproductive potential who refuse to use appropriate contraceptive measures during the study
- Patients who participated in other clinical trials within 4 weeks before enrollment
- Patients whom the investigator deems unsuitable for participation in the study
The study team makes the final eligibility decision.
Where it's taking place
- Shantou, Guangdong, 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 Shantou, Guangdong, 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.