Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK112 with SCRT and CapeOX, AK112 with SCRT.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
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.
Interventions
- 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). - 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).
Primary outcome measures
- Complete Response Rate [Time frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).]
Secondary outcome measures (9)
- Adverse Events (AEs) [Time frame: 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).]
- Objective Response Rate (ORR) [Time frame: Approximately 12 weeks after treatment initiation.]
- Progression-Free Survival (PFS) [Time frame: Up to 36 months post-randomization.]
- Overall Survival (OS) [Time frame: Up to 36 months post-randomization.]
- Organ Preservation Rate (OPR) [Time frame: Approximately 12 months post-treatment initiation.]
- Tumor Response Based on RECIST 1.1 [Time frame: Approximately 12 weeks after treatment initiation.]
- Clinical Complete Response Rate (cCR) [Time frame: Approximately 12 weeks after treatment initiation.]
- Pathological Complete Response (pCR) [Time frame: Approximately 12 weeks after treatment initiation.]
Eligibility criteria
Inclusion criteria
- 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.
9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge
Exclusion criteria
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Daping Hospital — Chongqing
Identifiers
NCT: NCT06718543 · TRIUNITE-03