NCT07175636Not yet recruitingPhase 2
QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer
A Multicenter, Prospective, Phase II Clinical Trial of Short-Course Radiotherapy Followed by QL1706 Plus mFOLFOX6 as Total Neoadjuvant Therapy for Patients With pMMR/MSS Locally Advanced Rectal Cancer
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody targeting PD-1 and CTLA-4, code name only) plus mFOLFOX6 chemotherapy in patients with locally advanced rectal cancer (LARC) with proficient mismatch repair/microsatellite-stable (pMMR/MSS) biology. Patients with pMMR/MSS disease derive limited benefit from immune checkpoint inhibition alone. Preclinical and clinical evidence suggests that SCRT and oxaliplatin-based chemotherapy can enhance antitumor immunity (e.g., antigen release, T-cell infiltration), providing a biological rationale for combining QL1706 with SCRT-primed TNT. Eligible adults with cT3-4 and/or N+ mid-to-low rectal adenocarcinoma (without distant metastasis), confirmed pMMR/MSS, and ECOG 0-1 will receive: SCRT (total 25 Gy over 5 fractions), then several cycles of QL1706 plus mFOLFOX6 as neoadjuvant systemic therapy. Definitive total mesorectal excision (TME) is planned per multidisciplinary assessment; a watch-and-wait approach may be considered for patients achieving a stringent clinical complete response per institutional criteria. Standard perioperative care and postoperative follow-up will be performed. Primary endpoint is pathologic complete response (pCR, ypT0N0) rate at surgery. Key secondary endpoints include: clinical complete response (cCR) rate, major pathologic response rate, R0 resection rate, tumor downstaging, radiologic response, disease-free survival (DFS), overall survival (OS), organ preservation rate (for patients managed non-operatively), surgical morbidity, and safety/tolerability (CTCAE v5.0). Exploratory endpoints include correlations between efficacy and baseline clinicopathologic features; optional translational analyses may investigate immune-inflammation markers related to response and resistance. This trial aims to determine whether SCRT-primed QL1706 plus mFOLFOX6 TNT can improve tumor eradication and organ preservation while maintaining acceptable safety in pMMR/MSS LARC-a population with unmet need for effective immunotherapy-based strategies.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 9 Sept 2025
- Start date
- 20 Sept 2025
- Primary completion date
- 20 Sept 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07175636
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 66
- From 20 Sept 2025 to the primary completion date, 20 Sept 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ).
Other illness
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis.
- Known allergy or hypersensitivity to study drugs or excipients.
- Uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia).
- Any condition judged by investigators to make the patient unsuitable for the study.
Other
- Evidence of distant metastasis.
- Pregnant or breastfeeding women.
Who the study is looking for
- Age 18-75 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Locally advanced disease (cT3-4 and/or N+, M0) based on pelvic MRI and/or CT.
- Tumor located within 12 cm from the anal verge.
- Proven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status.
- ECOG performance status 0-1.
- Adequate organ function:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- ALT/AST ≤ 2.5 × ULN
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
- No prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer.
- Signed written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.