Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer (TRIUNITE-03)

April 8, 2025 updated by: fan li

A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer

This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is designed as a two-arm, randomized, open-label, prospective trial. Patients with locally advanced rectal adenocarcinoma will be randomly assigned to one of two treatment groups:

Arm A: SCRT followed by chemotherapy (CapeOX) combined with AK112. Arm B: SCRT followed by AK112 alone. Primary and secondary outcome measures include complete response rate (CR), safety, pathological and radiological response rates, and biomarkers associated with treatment response. The trial will enroll 100 participants across multiple centers over three years.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Haode Shen, MD
  • Phone Number: +8617783437391
  • Email: imshd@qq.com

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Daping Hospital
        • Contact:
          • Haode Shen, MD
          • Phone Number: +8617783437391
          • Email: imshd@qq.com
        • Contact:
        • Contact:
          • Fan Li, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed written informed consent.
  2. Age 18-80 years, male or female.
  3. Histologically confirmed rectal adenocarcinoma.
  4. Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
  5. Able to swallow tablets.
  6. ECOG Performance Status of 0-1.
  7. No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.

9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge

Exclusion Criteria:

  1. Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
  2. Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.

4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).

7.Severe infection within 4 weeks or active pulmonary infections. 8.Active hepatitis B or C infection. 9.Diagnosis of other malignancies within 5 years (except low-risk cancers). 10.Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCRT followed by CapeOX regimen combined with AK112

Patients will receive short-course radiotherapy (SCRT) followed by chemotherapy (CapeOX regimen) combined with AK112:

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).
Drug: AK112 with SCRT and CapeOX
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).
Other Names:
  • short-course radiotherapy
  • CapeOX
Experimental: SCRT followed by AK112

Patients will receive short-course radiotherapy (SCRT) followed by AK112:

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).
Drug: AK112 with SCRT
In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).
Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).
From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: From baseline to 90 days after the last treatment dose.
Incidence, type, and severity of adverse events graded according to CTCAE v5.0, including their correlation with the study drug.
From baseline to 90 days after the last treatment dose.
Major Pathological Response (MPR)
Time Frame: At the time of surgery (approximately 12 weeks after treatment initiation).
Proportion of patients with ≤10% residual viable tumor cells in resected specimens.
At the time of surgery (approximately 12 weeks after treatment initiation).
Objective Response Rate (ORR)
Time Frame: Approximately 12 weeks after treatment initiation.
Proportion of patients with complete response (CR) or partial response (PR) based on radiological assessments using RECIST 1.1 criteria.
Approximately 12 weeks after treatment initiation.
Progression-Free Survival (PFS)
Time Frame: Up to 36 months post-randomization.
Time from randomization to disease progression or death from any cause.
Up to 36 months post-randomization.
Overall Survival (OS)
Time Frame: Up to 36 months post-randomization.
Time from randomization to death from any cause.
Up to 36 months post-randomization.
Organ Preservation Rate (OPR)
Time Frame: Approximately 12 months post-treatment initiation.
Proportion of patients avoiding major surgery while retaining organ functionality.
Approximately 12 months post-treatment initiation.
Tumor Response Based on RECIST 1.1
Time Frame: Approximately 12 weeks after treatment initiation.
Evaluation of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) using RECIST 1.1 criteria.
Approximately 12 weeks after treatment initiation.
Clinical Complete Response Rate (cCR)
Time Frame: Approximately 12 weeks after treatment initiation.
Proportion of patients achieving clinical complete response based on clinical examination and imaging assessments.
Approximately 12 weeks after treatment initiation.
Pathological Complete Response (pCR)
Time Frame: Approximately 12 weeks after treatment initiation.
Absence of tumor cells in the primary tumor and regional lymph nodes in surgical specimens.
Approximately 12 weeks after treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

fan li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIUNITE-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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