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

Fujian Medical University (FJMU)

Status: Enrolling

Conditions: Radiation Oncology; Rectal Cancer

Treatments: Drug: Tislelizumab; Radiation: split-course HFRT; Drug: CAPOX chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05176964

FujianUnionH-HFRT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

HFRT with concurrent chemotherapy and immunotherapy

Description:

CAPOX chemotherapy plus tislelizumab treatment plus split-course HFRT

Treatment:

Drug: CAPOX chemotherapy

Drug: Tislelizumab

Radiation: split-course HFRT