Rectal Cancer Clinical Trial
Official title:
Combined Chemotherapy and Tislelizumab With Preoperative Split-course Hypofraction Radiotherapy for Locally Advanced Rectal Cancer:Study Protocol of a Prospective, Single-arm Phase II Trial
The question of how to administer adequate chemotherapy and immunotherapy to synchronise hypofraction radiotherapy (HFRT) treatment strategy to maximise the benefits of neoadjuvant therapy for the improved prognosis of patients with locally advanced rectal cancer (LARC).We aimed to study whether chemotherapy and tislelizumab plus split-course HFRT results in better outcomes in LARC patients.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Treatment-naïve patients with operable locally advanced cancer (LARC, T3-4 and/or N+) - Pathologically diagnosed as rectal adenocarcinoma - Male or non-pregnant female - Age: 18-70 years old - Hematology examination:I. White blood cell count =4×10^9/L;II. Neutrophils =1.5×10^9/L;III. Platelet count =100×10^9/L;IV. Hemoglobin =9g/L - Blood biochemical examination: total bilirubin, AST, ALT=2.0×upper limit of normal; creatinine=1.5×upper limit of normal - Functional status: ECOG score 0-1 points or KPS score =70 points - Obtain the patient's informed consent Exclusion Criteria: - Pathologically diagnosed as non-adenocarcinoma - Age> 70 years old - Patients with recurrence and distant metastasis - Have a history of other malignancies - Have had radiotherapy and/or chemotherapy - Pregnant or breastfeeding women - Mentally disordered - Patients with severe heart, liver, and kidney damage - Non-compliance or the investigator believes that the patient cannot complete the entire trial treatment |
Country | Name | City | State |
---|---|---|---|
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Fujian Medical University Union Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pathological complete response(pCR) | pCR is defined as no residual tumor in the surgical specimen. | 1 year | |
Secondary | 3-year disease-free survival | the time from randomization to disease recurrence or patient death due to disease progression. | 2 years | |
Secondary | local recurrence rate | It's defined as disease-free proximal, distal and circumferential margins.And its progression was defined as an increase in tumor size. | 3 years | |
Secondary | overall survival(OS) | It's defined as the time after the first dose of study therapy to death from any cause. | 5 years | |
Secondary | Sphincter-sparing surgery rate | sphincter-sparing surgery rate | 1 year | |
Secondary | R0 Resection Rate(R0-R) | It's defined as the percentage of patients undergoing resection, defined as a tumour-free resection margin. | 1 year | |
Secondary | predictive biomarkers andquality of life(QoL) | Objective condition index include subjective perception index objective condition index and subjective perception index. | 3 years |
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