RecruitingPhase 2NCT06266832

The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma

The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma: A Prospective, Single-arm Study


Sponsor

Sir Run Run Shaw Hospital

Enrollment

30 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach before surgery for patients with rectal cancer located very close to the anus — using a short course of radiation plus immunotherapy (adebrelimab) and chemotherapy (CAPEOX) — with the goal of shrinking the tumor enough to potentially save the rectum and avoid a permanent colostomy bag. **You may be eligible if...** - You are 18 or older - You have rectal adenocarcinoma where the tumor is within 5 cm of the anus - Your cancer is Stage I, II, or III - Your cancer has tested negative for a certain DNA repair defect (MSS or pMMR) - You have not yet received any cancer treatment (chemotherapy, radiation, or immunotherapy) - Your general health is good (ECOG performance status 0–1) **You may NOT be eligible if...** - You have a defect in DNA mismatch repair (dMMR/MSI-H) - You have received prior treatment for this cancer - You have certain immune conditions or serious organ problems 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

DRUGAdebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

DRUGOxaliplatin

130mg/m2, ivgtt, d1, Q3W

DRUGCapecitabine

1000mg/m2, po, bid, d1-14, Q3W

RADIATIONShort-course Radiation

Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.

PROCEDUREBiopsy

local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.


Locations(1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06266832


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