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

ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
Sponsorfan li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.

Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SCRT followed by CapeOX regimen combined with AK112Experimental treatment 1 intervention
Group B: SCRT followed by AK112Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response Rate

Proportion of patients achieving either a pathological complete response (pCR) or a clinical complete response (cCR).

Time frame
From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).

Secondary outcomes

1

Adverse Events (AEs)

Incidence, type, and severity of adverse events graded according to CTCAE v5.0, including their correlation with the study drug.

Time frame
From baseline to 90 days after the last treatment dose.
2

Major Pathological Response (MPR)

Proportion of patients with ≤10% residual viable tumor cells in resected specimens.

Time frame
At the time of surgery (approximately 12 weeks after treatment initiation).
3

Objective Response Rate (ORR)

Proportion of patients with complete response (CR) or partial response (PR) based on radiological assessments using RECIST 1.1 criteria.

Time frame
Approximately 12 weeks after treatment initiation.
4

Progression-Free Survival (PFS)

Time from randomization to disease progression or death from any cause.

Time frame
Up to 36 months post-randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

fan li

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor institution

Source ClinicalTrials.gov
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