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Colorectal CancerPhase 2NCT07229872

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

A Phase 2 study testing Aipalolitovorelizumab and Fruquintinib in people with Colorectal Cancer, run by Harbin Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Aipalolitovorelizumab and Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
Dec 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a full understanding of this study and voluntarily sign the informed consent form;
  • Aged 18 - 75 years;
  • Patients must be pathologically confirmed as advanced, metastatic or recurrent microsatellite stable (MSS) colorectal cancer (detected by immunohistochemistry, PCR or NGS according to the detection standards of each institutional testing center);
  • The results of patients' genetic testing show no POLD1/POLE mutations;
  • At least one immune marker is positive:
  • PD-L1 CPS score ≥ 10 points, and positive for tumor-infiltrating CD8+ T cells;
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  • TMB ≥ 10 Muts/mb, and positive for tumor-infiltrating CD8+ T cells; ③ Functional mutations in epigenetic genes such as ARID1A, KMT2A/B/C/D, TET1/2/3, etc., and positive for tumor-infiltrating CD8+ T cells; ④ Presence of positive tertiary lymphoid structures (TLS) in the tumor microenvironment;
  • Patients have previously received two or more treatment regimens for advanced or metastatic colorectal cancer, at least one of which includes fluorouracil; or patients have previously received one treatment regimen for advanced or metastatic colorectal cancer and cannot tolerate the second-line standard chemotherapy regimen;
  • ECOG performance status of 0 - 1, with no deterioration within 7 days;
  • Expected survival ≥ 3 months;
  • Organ function levels must meet the following requirements:
  • Sufficient bone marrow reserve: absolute neutrophil count ≥ 1.5×10⁹/L, platelet count ≥ 90×10⁹/L, hemoglobin ≥ 9 g/dL; no blood transfusion or use of blood products within 14 days;
  • Liver: plasma albumin ≥ 2.8 g/dL; bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5×ULN, and if there is liver metastasis, ALT and AST ≤ 5×ULN; ③ Kidney: serum creatinine ≤ 1.5×ULN;
  • Heart: left ventricular ejection fraction (LVEF) ≥ 50%; ⑤ Coagulation: prothrombin time (PT) ≤ 1.5×ULN, international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤ 1.5×ULN; ⑥ Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously; if FT3 and FT4 levels are normal, patients can be enrolled);
  • Women of childbearing age need to take effective contraceptive measures;
  • Have good compliance and be cooperative with follow-up;
  • Agree to provide sufficient previously stored tumor tissue samples for testing.

Who cannot join

  • Unable to comply with the study protocol or research procedures;
  • Pregnant or lactating women;
  • Any factors affecting oral administration;
  • Patients who have previously received immunotherapy and fruquintinib;
  • Complicated with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmia, and heart failure;
  • Patients who participated in clinical studies of other drugs within 4 weeks before enrollment;
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  • Alcohol or drug abuse within 4 weeks after the last clinical trial;
  • Anti-infective treatment did not stop 14 days before the start of the study;
  • Severe uncontrolled systemic diseases, such as severe active infections;
  • Urinalysis shows urine protein > ++, and it is confirmed that 24-hour urine protein > 1.0 g;
  • Active bleeding within 3 months; severe arterial/venous thrombotic events within 6 months; hereditary or acquired bleeding (e.g., coagulation dysfunction); major surgery (except biopsy and electroresection of polyps) within 4 weeks before the study, incompletely healed surgical incisions, or major trauma; use of aspirin (> 325 mg/day) or current or recent use of dipyridamole, clopidogrel, and cilostazol (10 days before the study);
  • Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass grafting within 6 months before the first treatment;
  • Use of systemic glucocorticoids or other systemic immunosuppressive drugs within 2 weeks before treatment. Immunosuppressive drugs have been started or are expected to be used during the trial. Physiological replacement doses are allowed for inhaled glucocorticoids;
  • Fractures or long-term unhealed wounds;
  • Inactivated vaccines 接种 within 4 weeks before enrollment;
  • Having other malignant tumors within 5 years before enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin after radical resection, or carcinoma in situ of the cervix;
  • Known to be infected with human immunodeficiency virus (HIV), or positive for syphilis test, or known to be HIV-positive patients;
  • Previously received allogeneic bone marrow transplantation or organ transplantation;
  • Subjects allergic to the study drug or any of its auxiliary preparations;
  • Electrolyte abnormalities judged by the researcher to be clinically significant;
  • Detectable untreated chronic hepatitis B, chronic hepatitis B virus (HBV) carriers (HBV DNA > 2000 IU/mL), or HCV carriers with detectable HCV RNA. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 2000 IU/mL) can be included in the study;
  • Previous radiation pneumonitis or chest CT scan showing active pneumonia within 4 weeks before the study;
  • The patient has an autoimmune disease requiring intervention;
  • Accompanied by brain metastasis, or severe malignant pleural or peritoneal effusion;
  • Any other diseases, clinically significant metabolic abnormalities, abnormal physical examination or laboratory test results, which, in the researcher's judgment, reasonably suggest that the patient has a disease or condition unsuitable for the use of the study drug (such as having epileptic seizures requiring treatment), or will affect the interpretation of study results, or put the patient at high risk;
  • Patients deemed inappropriate for inclusion in this study by the researcher.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yanqiao Zhang, PhD contact

+86 138 4512 0210

yanqiaozhang@ems.hrbmu.edu.cn

About this study

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?

Read more

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.

Read the detailed description

The immunodominant population in this study refers to the following:

  • PD-L1 CPS score ≥ 10 points, and positive for tumor-infiltrating CD8+ T cells;
  • TMB ≥ 10 Muts/mb, and positive for tumor-infiltrating CD8+ T cells; ③ Functional mutations in epigenetic genes such as ARID1A, KMT2A/B/C/D, TET1/2/3, etc., and positive for tumor-infiltrating CD8+ T cells; ④ Presence of positive tertiary lymphoid structures (TLS) in the tumor microenvironment.
Being tested
Aipalolitovorelizumab, Fruquintinib
Keywords
Colorectal cancer, Immunotherapy, Microsatellite stability, Immune advantage
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AipalolitovorelizumabDrug

    Aipalolitovorelizumab (QL1706) injection at a dose of 5mg/kg, administered intravenously on Day 1 of each 3-week treatment cycle.

  • FruquintinibDrug

    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.

Study groups in NCT07229872
Study groupRoleWhat they receive
Single-arm experimental groupExperimentalParticipants 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.
Receives: Drug: Aipalolitovorelizumab; Drug: Fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    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.

    Measured: 6 months

Secondary outcomes (4)

  1. Progression Free Survival

    Progression-Free Survival (PFS) refers to the time from the start of receiving treatment to the occurrence of objective tumor progression or the patient's death.

    Measured: 1 year

  2. Overall survival

    Overall survival defined as the time between signing the informed consent form to death due to various causes

    Measured: 2 years

  3. Disease Control Rate

    Disease Control Rate defined as the proportion of patients who achieved complete response (CR), partialresponse (PR), and stable disease (SD) according to RECIST v1.1.

    Measured: 6 months

  4. Safety

    Use NCl-CTCAE version 5.0 for classification and grading

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07229872
Sponsor's protocol ID
QL-CRC-QIBA-3007
Status last verified
Nov 2025
First submitted
5 Aug 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aipalolitovorelizumab and Fruquintinib in people with Colorectal Cancer, run by Harbin Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanqiao Zhang, PhD (+86 138 4512 0210, yanqiaozhang@ems.hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07229872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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