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NCT07229872
A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment
Phase 2 trial testing Aipalolitovorelizumab in Colorectal Cancer in 18 participants. Not yet recruiting.
1 December 2026
Quick facts
| Lead sponsor | Harbin Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 December 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
Drugs / interventions tested
- Aipalolitovorelizumab — full drug profile →
- Fruquintinib — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Harbin Medical University
Who can join
Adults 18 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Objective Response Rate
Time frame: 6 months
Objective Response Rate (ORR) refers to the proportion of patients who achieve complete response (CR) and partial response (PR) after treatment among the total number of evaluable patients.
Sponsor's own description
The goal of this clinical trial is to explore the preliminary efficacy and tolerability of Aipalolitovorelizumab (QL1706) in combination with fruquintinib for the treatment of metastatic colorectal cancer patients with immunodominant pMMR/MSS type who have failed second-line or above treatment. It is an open-label, single-arm, single-center phase II trial. The main questions it aims to answer are: What is the objective response rate (ORR) of this combination therapy? What are the outcomes in terms of progression-free survival (PFS), overall survival (OS), and disease control rate (DCR)? What are the safety profiles and tolerability of the treatment? Participants will receive: Aipalolitovorelizumab (QL1706) injection at a dose of 5mg/kg, administered intravenously on Day 1 of each 3-week treatment cycle. Fruquintinib at a dose of 5mg per day, taken orally continuously for the first 2 weeks of each 3-week cycle, followed by 1 week of withdrawal. The treatment will continue until disease progression as assessed by RECIST v1.1 criteria, occurrence of unacceptable toxicity, decision to withdraw by the doctor or patient, non-compliance, or discontinuation due to administrative reasons. Participants will be monitored throughout the trial period to evaluate the efficacy and safety of the treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07229872
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
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- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
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Other Harbin Medical University trials
Trials by the same sponsor.
- NCT07471815 — Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mecha · Phase 2 · active not recruiting
- NCT07187674 — The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonr · NA · not yet recruiting
- NCT07161791 — Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07033624 — Cardiovascular Risk Early Screening and Warning in Harbin : A Prospective Cohort Study · not yet recruiting
- NCT06947148 — The Impact of Comprehensive Post Hospital Management Based on DHI on Cardiac Function in Patients With HF · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07229872 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harbin Medical University
- Last refreshed: 13 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07229872.
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