Neoadjuvant Chemoradiotherapy Combined With QL1706 for MSS-Type Low-Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital
About this trial
he goal of this prospective, exploratory clinical trial is to learn if neoadjuvant chemoradiotherapy combined with QL1706 (a dual PD-1/CTLA-4 antibody) can effectively treat in patients with MSS-type low rectal cancer (tumor lower edge ≤ 7cm from the anal verge, aged 18-75). The main questions it aims to answer are:
What is the complete response (CR) rate, including clinical complete response (cCR) and pathological complete response (pCR)? What are the 3-year and 5-year overall survival (OS) and disease-free survival (DFS) rates?
Researchers will compare two cohorts of patients based on tumor stage (Cohort 1: early low rectal cancer cT1-3N0M0; Cohort 2: locally advanced low rectal cancer cT4N0M0 or cTanyN+M0) to see if the combination treatment yields different efficacy and safety outcomes depending on the disease stage.
Participants will:
Receive either short-course radiotherapy (25Gy/5 fractions) or long-course radiotherapy (50Gy/25 fractions) based on their assigned cohort.
Receive 4 cycles of chemotherapy (Capeox: Capecitabine + Oxaliplatin) combined with QL1706.
Undergo assessments including pelvic MRI, endorectal ultrasound, and digital rectal exams to evaluate tumor regression.
Based on the tumor response, undergo surgery (radical resection or local excision) or enter a Watch \& Wait follow-up protocol.
Provide blood, urine, stool, and tissue samples for biomarker and exploratory analyses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing to receive neoadjuvant therapy.
Age 18-75 years; any gender.
Histopathologically confirmed rectal adenocarcinoma.
Low rectal cancer confirmed by colonoscopy, endoscopic ultrasound, and high-resolution pelvic MRI, with the tumor lower edge ≤7 cm from the anal margin and no distant metastases.
Disqualifiers
History of malignant colorectal tumors.
Intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
Known allergy to capecitabine, oxaliplatin, PD-L1 antibodies, CTLA-4 antibodies, or similar drugs.
Pathology indicating poorly differentiated adenocarcinoma or signet-ring cell carcinoma.
Trial design
Design model
Parallel
Treatments tested in this trial
Neoadjuvant short-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab
DrugShort-course chemoradiotherapy was administered, with a total tumor dose of 25 Gy to the primary tumor and high-risk areas (5 Gy per session, 5 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were given (every 3 weeks): On Day 1, QL706 was administered at 5 mg/kg via intravenous infusion; oxaliplatin was given at 130 mg/m² via intravenous infusion. From Day 1 to Day 14, capecitabine was taken orally at 850-1000 mg/m², twice daily.
Neoadjuvant long-term radiotherapy and chemotherapy + iparomlimab and tuvonralimab
DrugLong-term radiotherapy was administered to the primary tumor and high-risk areas, with a total dose of 50 Gy (2 Gy per session, 25 sessions in total). After completion of radiotherapy, a 2-week rest period was allowed. Following that, 4 cycles of Capoex combined with QL706 were administered (every 3 weeks): On Day 1, QL706 was given at a dose of 5 mg/kg via intravenous infusion; oxaliplatin was administered at a dose of 130 mg/m² via intravenous infusion from Day 1 to Day 14. Capecitabine was taken orally at a dose of 850-1000 mg/m², twice daily, from Day 1 to Day 14.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Early rectal cancer at a low stage（cT1-3N0M0）Experimental treatment 1 intervention
Group B: Low-stage locally advanced rectal cancer (cT4N0M0 or cTanyN+M0)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The rate of CR
:Rate of patients who achieve complete remission（cCR rate +pCR rate）
Time frame
Up to 24 monthsSecondary outcomes
1
Overall survival(OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Time frame
Up to 36 months2
Disease free survival(DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Time frame
Up to 36 months3
Overall survival(OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.
Time frame
Up to 60 months4
Disease free survival(DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Time frame
Up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov