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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05176964
Other study ID # FujianUnionH-HFRT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 31, 2021
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source Fujian Medical University Union Hospital
Contact Benhua Xu
Phone 86+13696884375
Email benhuaxu@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
split-course HFRT
7Gy/F, d7, q3w, 5 cycles
Drug:
CAPOX chemotherapy
CAPOX chemotherapy will commence on day 1 for each of six cycles: oxaliplatin 130 mg/m^2 intravenous infusion on day 1,followed by capecitabine 1000 mg/m^2 administered orally twice daily on day 1 to 14 of a 21-day cycle.
Tislelizumab
Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.

Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

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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