Clinical trial NCT05176964: Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Radiation Oncology
Keywords: chemotherapy
tislelizumab
split-course hypofraction radiotherapy
locally advanced rectal cancer
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hosptal in-patients

Brief summary: 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.

Detailed description: Prior to analyzing continuous variables, the statistical normality of the data will be determined. The differences between the main variables will be compared by using the analysis of variance. A comparison of data on categorical variables will be carried out by χ2 tests or Fisher's exact tests. The OS and PFS was estimated using the Kaplan-Meier method. PFS and OS will be compared using the log-rank test. In cases where variables must be adjusted, we will use the proportional hazard Cox regression model. P values for all analyses will be based on using a significance level of 0.05.

Eligibility criteria: 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

Primary outcomes:
measure: pathological complete response(pCR)
timeFrame: 1 year
Secondary outcomes:
measure: 3-year disease-free survival
timeFrame: 2 years
measure: local recurrence rate
timeFrame: 3 years
measure: overall survival(OS)
timeFrame: 5 years
measure: Sphincter-sparing surgery rate
timeFrame: 1 year
measure: R0 Resection Rate(R0-R)
timeFrame: 1 year
measure: predictive biomarkers andquality of life(QoL)
timeFrame: 3 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Benhua Xu
role: PRINCIPAL_INVESTIGATOR
References: