RecruitingPhase 2NCT06204094

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

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


Sponsor

Jinhua Central Hospital

Enrollment

37 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a treatment approach for mid-to-low rectal cancer that aims to preserve the anus — combining targeted radiation, chemotherapy (CAPOX), and an immunotherapy drug (sintilimab) before surgery, to increase the chance of avoiding a permanent colostomy bag. **You may be eligible if...** - You have rectal cancer within 10 cm of the anal opening, confirmed by imaging and biopsy - Your tumor is locally advanced (stage T2-T4) but has not spread to distant organs - Your cancer is microsatellite stable (MSS) — a specific tumor type that is common - You have not received any prior cancer treatment - You are between 18 and 75 years old and in reasonably good health (ECOG 0–1) - You strongly want to preserve the anus and avoid a colostomy **You may NOT be eligible if...** - Your cancer has spread to organs outside the pelvis - You have received any prior chemotherapy, radiation, or immunotherapy - Your blood counts or organ function do not meet minimum levels - You have serious heart, liver, or immune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONnode-sparing short-course radiotherapy

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

DRUGSintilimab

200mg intravenous infusion d1 of each cycle\*6cycles

DRUGCapecitabine

1000mg/m2, PO, BID, d1-14 of each cycle\*6cycles

DRUGOxaliplatin

130mg/m2, intravenous infusion,d1 of each cycle\*6cycles

PROCEDURETME surgery

laparoscopic or robotic TME surgery for non-cCR patients

PROCEDUREwatch and wait

WW for cCR patients


Locations(1)

Zhejiang University Affiliated Jinhua Hospital

Jinhua, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06204094


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