SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2028

Conditions
Rectal CancerRadiationAK112
Interventions
RADIATION

radiotherapy

The patients receive pelvic radiotherapy: Intensity-Modulated Radiation Therapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT), with a total dose of 25 Gy delivered in 5 fractions. Radiotherapy is to start on day 1 and to finish on day 5.

DRUG

Ivonescimab (20mg/kg Q3W)

The first dose of vonescimab (AK112) was administered 1 week after the completion of radiotherapy. Ivonescimab (AK112) was initiated at a dose of 20 mg/kg via intravenous infusion on Day 1 of each 21-day cycle, for a total of 6 cycles.

OTHER

Non-operative Management

Subjects who achieve cCR after radiation and 6 cycles treatment of Ivonescimab can, after discussion with the local investigator, decline surgery and opt for a non-operative management.

PROCEDURE

Surgery

For patients who do not achieve cCR at the end of 6 cycles treatment of Ivonescimab, TME surgery is recommended.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Akeso

INDUSTRY

lead

Zhejiang Cancer Hospital

OTHER

NCT07162714 - SCRT Followed by AK112 in pMMR/MSS Mid-low Rectal Cancer | Biotech Hunter | Biotech Hunter