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Neoadjuvant Preoperative Arterial Intervention With Concurrent Chemoradiotherapy in Local Advanced Rectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To increase the efficacy of neoadjuvant PD-1/PD-1 checkpoint inhibitor in local advanced rectal cancer (LARC), we propose preoperative arterial infusion of Tirellizumab and oxaliplatin followed by tumor artery embolization with concurrent chemoradiotherapy as neoadjuvant regimen for LARC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Local advanced Rectal cancer: stage T3/4NanyM0 or T1-2N+M0.

• Ages: 18 to 75.

• No previously received chemotherapy drugs and radiation therapy.

• ECOG score: 0 - 2.

• Appropriate organ function, as defined below:

⁃ (Hematology and blood biochemistry examination must be completed within 7 days before the registration date) i) White blood cell count ≥ 4,000/mm3. ii) Neutrophil count ≥ 1,500/mm3. iii) Hemoglobin ≥ 10 g/dL. iv) Platelet count ≥ 100,000/mm3. v) Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). vi. Liver function Index (AST \& ALT) ≤ 1.5 times the upper limit of normal (ULN).

⁃ vii. Serum creatinine ≤1.5 times the upper limit of normal or creatinine clearance ≥60 ml/min.

• Tolerance of orally administration of capecitabine.

• Can understand the study, have good compliance, cooperate with follow-up.

Locations
Other Locations
China
Daping Hospital, Third Military Medical University
RECRUITING
Chongqing
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 90
Treatments
Experimental: local advanced rectal cancer
local advanced rectal cancer are defined as T3/4NanyM0 or T1-2N+M0
Related Therapeutic Areas
Sponsors
Leads: Third Military Medical University

This content was sourced from clinicaltrials.gov