Chemotherapy and Tislelizumab With Split-course HFRT for Locally Advanced Rectal Cancer

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176964
• Other study ID #: FujianUnionH-HFRT
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Radiation Oncology
• Rectal Cancer
• Rectal Neoplasms

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