Primary Objectives: Evaluate the complete response rate (CR rate) and safety of short - course radiotherapy combined with ivonesimab (AK112) in patients with pMMR/MSS mid - low rectal cancer. Secondary Objectives: Evaluate treatment - related toxic reactions, the quality of life, long - term prognosis (local control \[LC\], disease - free survival \[DFS\] and overall survival \[OS\]). Patients will : Receive Radiotherapy: Pelvic IMRT or VMAT, DT 25Gy/5Fx. One week after radiotherapy, begin treatment with Ivorsimab (AK112) at a dose of 20mg/kg by intravenous drip on day 1. One cycle is 21 days, and a total of 6 cycles are to be carried out. Evaluate the curative effect after 3 cycles of treatment. Patients with progressive disease (PD) will withdraw from the study, and other treatment plans will be adjusted in a timely manner. Patients with CR/PR/SD will continue treatment for another 3 cycles. Conduct a comprehensive assessment after 6 cycles of treatment. Patients who achieve cCR can choose the watch - and - wait approach. For patients who do not achieve cCR, TME surgery is recommended. Decide whether to perform adjuvant chemotherapy based on the postoperative pathological findings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
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.
For patients who do not achieve cCR at the end of 6 cycles treatment of Ivonescimab, TME surgery is recommended.
Zhejiang cancer hosptial
Hangzhou, Zhejiang, China
RECRUITINGComplete remission rate (CR rate)
including clinical complete response rate (cCR) and pathological complete response rate (pCR). pCR status is defined as the absence of resected speci mens with surviving tumour cells. cCR is defined as undetectable signs of tumour at least 4 weeks after TNT completion by clinical ex amination, including magnetic resonance imaging (MRI), endoscopy, digital rectal examination (DRE) and Positron Emission Tomography-Computed Tomography (PET-CT).
Time frame: at the end of 6 cycles of AK112 treatment (each cycle is 21 days) or after surgery
Treatment - related adverse reactions
Number of Participants with Treatment - related adverse reactions according to CTCAE 5.0
Time frame: From enrollment to 6 months after the last administration of study treatment
locoregional control rate
from the date of registration to the date of occurrence of locoregional recurrence, or death due to any cause.
Time frame: Up to 3 years after the last administration of study treatment
disease-free survival rate
from the date of registration to the date of occurrence of any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Time frame: Up to 3 years after the last administration of study treatment
Overall survival rate
from the date of registration to the date of death from any cause.
Time frame: Up to 3 years after the last administration of study treatment
Qol EORTC-C30 questionnaire
Time frame: From enrollment to 6 months after the last administration of study treatment
Qol EORTCQLQ- CR29 questionnaire
Time frame: From enrollment to 6 months after the last administration of study treatment
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