NCT05176964

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer
• Radiation Oncology

Interventions

Type	Name	Description
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.
DRUG	Tislelizumab	Tislelizumab 200 mg intravenous infusion on day 1 of each 21-day cycle for each of six cycles.

Timeline

• Start date: 2021-12-31
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-01-04
• Last updated: 2023-09-25

Locations

1 site across 1 country: China