Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With Simultaneous Integrated Boost Intensity-modulated Radiotherapy in the Treatment of Locally Advanced Rectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims to evaluate the efficacy and safety of tislelizumab combined with simultaneous integrated boost intensity-modulated radiotherapy in treating locally advanced rectal cancer. To explore a new PD-1 inhibitor adjuvant chemotherapy model combined with radiotherapy to treat locally advanced rectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Aged 18 to 70 years.

• The pathological type of rectal cancer diagnosed by histopathology is adenocarcinoma.

• Patients with T3-4 in the eighth AJCC stage or positive regional lymph node and no distant metastasis.

• Having at least one measurable lesion according to RECIST 1.1.

• ECOG score 0-1.

• Expected survival time ≥6 months.

• Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.

• Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Locations
Other Locations
China
First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 48
Treatments
Experimental: Experimental arm
The experimental group will receive concurrent simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) and concurrent capecitabine chemotherapy, and complete 2 \~ 4 cycles of XELOX chemotherapy, while receiving full tislelizumab treatment for at least 4 cycles (21 days per cycle).
Placebo_comparator: Control arm
The control group received intensity-modulated radiotherapy (IMRT) without tirellizumab, and the other treatment regiments were consistent with the experimental group.
Related Therapeutic Areas
Sponsors
Leads: Yong Zhang,MD

This content was sourced from clinicaltrials.gov