Actively Recruiting
Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
Led by Sun Yat-sen University · Updated on 2026-04-28
88
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, prospective, randomized, double-arm, Phase II clinical trial designed to evaluate the efficacy of short-term radiotherapy combined with Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as neoadjuvant therapy for locally advanced rectal cancer. Additionally, the study seeks to explore the relationship between biomarkers in blood, urine, feces, and tumor tissue and treatment efficacy. Eligible participants (pMMR/MSS locally advanced rectal cancer) were randomly assigned in a 1:1 ratio to two groups, with randomization stratified by MRF (+ vs. -). Participants will: * Group A patients received two cycles of QL1706, regorafenib, and CAPOX induction therapy, followed by sequential short-course radiotherapy, and then continued with four cycles of QL1706, regorafenib, and CAPOX consolidation therapy. * Group B patients received short-course radiotherapy followed by six cycles of QL1706, regorafenib, and CAPOX consolidation therapy. After two cycles of neoadjuvant therapy in Group A and six cycles in Group B, efficacy was evaluated and decisions regarding surgery or watchful waiting were made based on efficacy.
CONDITIONS
Official Title
Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed rectal adenocarcinoma with the lower tumor edge 12 cm or less from the anal verge
- Clinical stage cT3-4aN0M0 or cT1-4aN+M0
- pMMR confirmed by immunohistochemistry or MSS/MSI-L confirmed by PCR or NGS
- ECOG performance status 0 or 1
- Voluntary informed consent given
- No prior treatments targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery
- Surgery planned after completing neoadjuvant therapy
- Expected survival of 6 months or more
- Adequate organ and bone marrow function as defined by specific blood and biochemistry criteria
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after
- Male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 120 days after
- Good compliance and willingness to attend follow-up visits
- Agreement to provide blood, urine, stool, and tumor tissue samples
You will not qualify if you...
- Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment, except vitiligo or resolved childhood asthma without therapy
- Use of systemic corticosteroids or immunosuppressants within 14 days before first dose or immunostimulants within 4 weeks before first dose
- Receipt of live or attenuated live vaccines within 30 days before first dose or during the study
- Use of broad-spectrum antibiotics within 30 days before first dose
- Prior antitumor treatments including radiotherapy, chemotherapy, surgery (excluding biopsy), PD-1/CTLA-4 dual immunotherapy, regorafenib, or other tyrosine kinase inhibitors
- Unresectable tumors, surgical contraindications, or refusal of surgery
- Immunodeficiency including HIV or history of organ/bone marrow transplantation (except corneal transplantation)
- Hepatitis B or C infection with high viral load
- Other malignancies within 5 years except treated basal cell carcinoma or carcinoma in situ of the cervix
- Uncontrolled pleural, pericardial effusions, or ascites requiring drainage
- Severe pulmonary diseases like active tuberculosis or pneumonitis
- Renal failure requiring dialysis
- Active infection, fever above 38.5°C within 7 days prior to treatment, or high white blood cell count
- Significant cardiac conditions including heart failure, unstable angina, recent heart attack, arrhythmias needing treatment, or prolonged QTc interval
- Poorly controlled hypertension or history of hypertensive crisis
- Recent arterial or venous thrombosis within 6 months
- Known bleeding or clotting disorders
- Significant bleeding within 4 weeks prior to treatment
- Tumor invading major blood vessels with high bleeding risk
- Severe unhealed wounds, ulcers, or untreated fractures
- Major vascular disease requiring repair within 6 months
- Major surgery within 4 weeks before treatment or planned during study (excluding study procedures)
- Abdominal fistula, perforation, or abscess within 6 months
- Need for long-term or high-dose NSAIDs or anticoagulants
- Known allergy or severe hypersensitivity to study drugs or components
- Inability to swallow oral study drugs
- Pregnant or breastfeeding women
- Other factors affecting study outcomes or patient safety as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dept. of Colorectal Surgery, Sun Yat-sen University Cancer Center. Yuexiu District, Dongfeng East Road 651
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
K
Kai Han, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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