OncoMatch/Clinical Trials/NCT06911684
Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
Is NCT06911684 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including lparomlimab and Tuvonralimab and lparomlimab and Tuvonralimab for rectal cancer patients.
Treatment: lparomlimab and Tuvonralimab · lparomlimab and Tuvonralimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient mismatch repair
pMMR confirmed by immunohistochemistry (IHC) at the study center's pathology department
Required: MSH2 microsatellite stable
MSS/MSI-L confirmed by PCR or NGS
Disease stage
Required: Stage CT3-4AN0M0, CT1-4AN+M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: radiotherapy
No previous therapy targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery.
Cannot have received: chemotherapy
No previous therapy targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery.
Cannot have received: surgery
Exception: excluding biopsy
No previous therapy targeting rectal adenocarcinoma, including radiotherapy, chemotherapy, or surgery.
Cannot have received: PD-1/CTLA-4 dual immunotherapy
Any prior antitumor treatments (radiotherapy, chemotherapy, surgery [excluding biopsy], PD-1/CTLA-4 dual immunotherapy, regorafenib, or other tyrosine kinase inhibitors).
Cannot have received: tyrosine kinase inhibitor (regorafenib)
Any prior antitumor treatments (radiotherapy, chemotherapy, surgery [excluding biopsy], PD-1/CTLA-4 dual immunotherapy, regorafenib, or other tyrosine kinase inhibitors).
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥90 g/L
Kidney function
Serum creatinine ≤1.5 × ULN, or creatinine clearance (CrCl) ≥50 mL/min
Liver function
Total bilirubin ≤1.5 × ULN; ALT ≤2.5 × ULN, AST ≤2.5 × ULN; ALP ≤2.5 × ULN; Serum albumin ≥30 g/L
Adequate Organ and Bone Marrow Function, meeting all of the following (with no blood products, growth factors, or other hematopoietic-supportive medications used within 14 days before first administration): Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10^9/L Platelet count ≥100 × 10^9/L Hemoglobin ≥90 g/L Serum Biochemistry: Serum albumin ≥30 g/L Total bilirubin ≤1.5 × ULN ALT ≤2.5 × ULN, AST ≤2.5 × ULN Alkaline phosphatase (ALP) ≤2.5 × ULN Serum creatinine ≤1.5 × ULN, or creatinine clearance (CrCl) ≥50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06911684 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require MMR?
Yes, MMR proficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 microsatellite stable is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT3-4AN0M0 or CT1-4AN+M0 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages