RecruitingPhase 2NCT06234007

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study (UNION PRECISION-I)

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

45 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Rectal Cancer

Summary

To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combined approach before surgery for patients with locally advanced rectal cancer: short-course radiation therapy followed by a combination of three drugs — fruquintinib (targeted therapy), adebrelimab (immunotherapy), and CAPOX (chemotherapy). **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with locally advanced rectal cancer (adenocarcinoma) - Your tumor is high-risk on MRI scan (e.g., advanced stage or near important structures) - The bottom of your tumor is within 10 cm of the anus - You have not yet received any treatment for rectal cancer - You plan to have surgery after completing this treatment **You may NOT be eligible if...** - You have received prior surgery, radiation, chemotherapy, or immunotherapy for rectal cancer - You have significant heart, liver, kidney, or blood count problems - You are pregnant or not using adequate contraception 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

Safety run-in phase: Fruquintinib 4mg/d, oral, once daily, continuous treatment for 2 weeks, 1 week off, q3w, 6 cycles; If the number of patients experiencing dose-limiting toxicity (DLT) was ≤1, the study would continue at that dose level. If the number of patients with DLTs was \>1, the dose of fruquintinib was decreased to 3mg/d, qd po, d1-14, q3w, and the dose expansion phase was continued；Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles; Dose expansion phase: Fruquintinib RP2D, qd po, d1-14, q3w, 6 cycles; Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;

Locations(1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06234007

Related Trials

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

NCT062040941 location

A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer

NCT075270261 location

Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients

NCT075147541 location

GALENOS 1 in Head and Neck, Lung, and Rectal Cancer Patients

NCT075114131 location

CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer

NCT062814051 location