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RECRUITING
NCT06204094
PHASE2

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Sponsor: Jinhua Central Hospital

View on ClinicalTrials.gov

Summary

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Official title: Total Neoadjuvant CAPOX and PD-1 Inhibitor(Sintilimab) Combined with Node-sparing Short-course Radiotherapy for MSS Locally Advanced of Middle and Low Rectal Cancer(CASINOs): an Open Label, Single-arm, Prospective Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2024-02-05

Completion Date

2028-09-01

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

RADIATION

node-sparing short-course radiotherapy

5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes

DRUG

Sintilimab

200mg intravenous infusion d1 of each cycle\*8cycles

DRUG

Capecitabine

1000mg/m2, PO, BID, d1-14 of each cycle\*8cycles

DRUG

Oxaliplatin

130mg/m2, intravenous infusion,d1 of each cycle\*8cycles

PROCEDURE

TME surgery

laparoscopic or robotic TME surgery for non-cCR patients

PROCEDURE

watch and wait

WW for cCR patients

Locations (1)

Zhejiang University Affiliated Jinhua Hospital

Jinhua, Zhejiang, China