A Prospective, Randomized, Phase II Trial of MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

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

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

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

• Age 18-70 years old, male or female

• Pathologically confirmed rectal adenocarcinoma

• The distance from anal verge ≤ 10 cm

• Clinical stage T3-4 and/or N+

• No evidence of distance metastases

• MSI/MMR status: MSS/pMMR

• Karnofsky score \>=70

• Adequate organ function and have no contraindications to surgery, radiochemotherapy, or immunotherapy

• No chemotherapy or any other anti-tumor therapy prior to enrollment

⁃ No immunotherapy prior to enrollment

⁃ With good compliance during the study

⁃ Signed written informed consent

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Zhen Zhang, MD
zhen_zhang@fudan.edu.cn
+86 18017312217
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2027-02-12
Participants
Target number of participants: 46
Treatments
Experimental: Group A
The patients will receive conventional pelvic radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.
Experimental: Group B
The patients will receive lymph node-sparing radiotherapy (30Gy/6Fx), combined with 6 cycles of CAPOX and PD-1 antibody. TME surgery is scheduled after TNT.
Related Therapeutic Areas
Colorectal Cancer
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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