Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

NCT06802666 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-01-31

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer

Conditions

  • Locally Advanced Rectal Cancer
  • Neoadjuvant Therapy

Interventions

RADIATION

short-course radiotherapy

Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles.

DRUG

Ivonescimab

AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W)

DRUG

capecitabine

1000mg/m2, bid, po, d1-14,q3w

DRUG

oxaliplatin

130mg/m2, ivgtt, d1,q3w

PROCEDURE

TME surgery

The surgery was performed 1 week after the end of neoadjuvant therapy.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Tao Zhang, MD · Union Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2026-09-01
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802666 on ClinicalTrials.gov