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

NCT06718543 | Recruiting Phase 2 DMC

• 1 other identifier: TRIUNITE-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; neoadjuvant; Ivonescimab; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  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 Outcomes (9)

• Adverse Events (AEs)

  From baseline to 90 days after the last treatment dose.

• Major Pathological Response (MPR)

  At the time of surgery (approximately 12 weeks after treatment initiation).

• Objective Response Rate (ORR)

  Approximately 12 weeks after treatment initiation.

• Progression-Free Survival (PFS)

  Up to 36 months post-randomization.

• Overall Survival (OS)

  Up to 36 months post-randomization.

Study Arms (2)

SCRT followed by CapeOX regimen combined with AK112

EXPERIMENTAL

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

SCRT followed by AK112

EXPERIMENTAL

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

Interventions

AK112 with SCRT and CapeOX DRUG

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).

Also known as: short-course radiotherapy, CapeOX

SCRT followed by CapeOX regimen combined with AK112

AK112 with SCRT DRUG

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).

SCRT followed by AK112

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Age 18-80 years, male or female.
• Histologically confirmed rectal adenocarcinoma.
• Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
• Able to swallow tablets.
• ECOG Performance Status of 0-1.
• No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy.
• Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge

You may not qualify if:

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

Sponsors & Collaborators

• fan li: lead

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Fan LI, PhD

CONTACT

+8618696539200; levinecq@163.com

Haode Shen, MD

CONTACT

+8617783437391; imshd@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)