NCT06802666

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

Short-course Radiotherapy(SCRT) Followed by Ivonescimab(AK112) and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer(LARC）: A Single-arm, Single-center, Exploratory, Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study includes a screening period (from the time the participant signs the informed consent form until the first treatment, not exceeding 21 days), treatment period (including full neoadjuvant therapy, surgery, and postoperative adjuvant treatment), and follow-up period (including safety follow-up and survival follow-up ). 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: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W.The surgery was performed 1 week after the end of neoadjuvant therapy.After surgery, the investigator conducts a pathological assessment of the surgical specimen for response evaluation. Then, there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.

Conditions

• Locally Advanced Rectal Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-09-01
• Completion: 2027-12-30
• First posted: 2025-01-31
• Last updated: 2025-01-31

Locations

1 site across 1 country: China