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Colorectal CancerPhase 2NCT07229846

A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation

A Phase 2 study testing Aipalolitovorelizumab, XELOX + Bevacizumab and mFOLFOX + Bevacizumab in people with Colorectal Cancer, run by Yanqiao Zhang at 1 site in China.

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
Search all trials

Trial summary

This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E… 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, XELOX + Bevacizumab and mFOLFOX + Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Feb 2026to Feb 2028
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

  • Aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the ICF, male or female;
  • Patients with histopathologically confirmed unresectable metastatic colorectal adenocarcinoma of MSS/pMMR type with known BRAF V600E mutation;
  • Expected survival period ≥ 12 weeks;
  • No prior systemic antineoplastic drug treatment for metastatic colorectal adenocarcinoma (if the patient has previously received XELOX chemotherapy while waiting for genetic testing results, and meets other inclusion criteria as assessed by the researcher, they can be enrolled in the treatment);
  • For subjects who have received neoadjuvant/adjuvant therapy previously, the time from the last treatment to recurrence or progression must exceed 6 months;
  • Adverse events (AEs) related to previous treatment have recovered to grade ≤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (except for alopecia);
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  • According to the RECIST version 1.1 criteria, the researcher assesses that there is at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions located in the previously irradiated area can also be regarded as eligible measurable lesions if progression is confirmed);
  • Routine blood tests: No blood transfusion or use of blood products within 14 days. White blood cell count > 3000/µl, absolute neutrophil count (ANC) ≥ 1500 cells/µl, platelet count ≥ 75,000/µl, hemoglobin ≥ 9.0 g/dL, left ventricular ejection fraction (LVEF) ≥ 50%, Fridericia-corrected QT interval (QTcF) < 470 milliseconds, activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN);
  • Bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 times ULN; if there is liver metastasis, ALT and AST ≤ 5 times ULN, total bilirubin (TBLL) ≤ 3 times ULN; creatinine < 1.5 times ULN;
  • ECOG PS score of 0-1 within 7 days before the first administration of the study drug;
  • Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-), and no active hepatitis is clinically determined. If HBsAg (+) or HBcAb (+), then hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be < 1000 copies/mL or 200 IU/mL (if the lower limit of detection in the research unit is > 200 IU/mL, subjects with results below the lower limit of detection can be enrolled);
  • Hepatitis C virus (HCV) antibody (-); if HCV antibody (+), HCV-RNA test must be negative for enrollment. Subjects with co-infection of hepatitis B and hepatitis C must be excluded (HBsAg or HBcAb positive, and HCV antibody positive);
  • For female subjects of childbearing potential, the blood pregnancy test within 7 days before the first drug administration must be negative. Female subjects of childbearing potential and male subjects whose partners are women of childbearing age need to use at least one medically recognized contraceptive method (such as intrauterine device, contraceptives, or condoms) during the study treatment period and until at least 3 months after the last use of Aipalolitovorelizumab (QL1706) and bevacizumab, and at least 6 months after the last use of chemotherapy (whichever occurs later);
  • Provide a signed ICF and be willing to comply with all research procedures and rules specified in the protocol;
  • Have good compliance and be cooperative with follow-up.

Who cannot join

  • Have other active malignant tumors within 5 years before the first administration of the study drug. Patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast can be enrolled;
  • Have central nervous system (CNS) or leptomeningeal metastasis;
  • Have received radiotherapy within 6 months before the start of study treatment; except for palliative radiotherapy for bone lesions performed more than 14 days before the start of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days before the first administration is not allowed;
  • Have previously received treatment with targeted drugs against EGFR or VEGF/vascular endothelial growth factor receptor (VEGFR) targets (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of the above drugs, etc.);
  • Have previously received any T-cell co-stimulation or immune checkpoint inhibitor therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell-targeted drugs;
  • Have a known history of severe allergy to any study drug analogs or study drug excipients;
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  • Pleural effusion, pericardial effusion that cannot be controlled by appropriate intervention, or ascites that requires frequent drainage;
  • Have had cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval ≥ 450 ms in males and ≥ 470 ms in females) within half a year (QTc interval is calculated by Fridericia formula);
  • Have New York Heart Association (NYHA) class III or IV cardiac insufficiency, or echocardiography shows left ventricular ejection fraction (LVEF) < 50%;
  • Have a history of immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation;
  • Have active pulmonary tuberculosis;
  • Patients with past or current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function, etc., which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity;
  • Have active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes). Except for the following subjects: patients with vitiligo or cured childhood asthma/allergies who do not need any intervention in adulthood; patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; type I diabetes mellitus using a stable dose of insulin;
  • Have received live attenuated vaccine treatment within 28 days before the first administration of the study drug;
  • Subjects who need continuous systemic treatment (> 7 days) with corticosteroids (> 10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressants within 14 days before the first administration of the study drug or during the study period. In the absence of active autoimmune diseases, inhalation or topical use of steroids, or adrenal hormone replacement with a dose ≤ 10 mg/day prednisone equivalent dose is allowed;
  • Have had a severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggests active pulmonary inflammation accompanied by clinically relevant symptoms or signs; have symptoms and signs of infection within 2 weeks before the first use of the study drug, or require oral or intravenous antibiotic treatment, except for the case of prophylactic use of antibiotics;
  • Have received major surgery within 28 days before the first administration of the study drug. Major surgery in this study is defined as surgery that requires at least 3 weeks of recovery before being able to receive treatment in this study;
  • Have previously received intestinal stent implantation, and the intestinal stent has not been removed by the screening period;
  • Have hypertension that cannot be controlled by clinical treatment (i.e., systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Have a history of hypertensive crisis or hypertensive encephalopathy;
  • CT/MRI images show that the tumor surrounds or invades the lumen of large blood vessels (such as pulmonary artery or superior vena cava);
  • Patients with a significant/severe bleeding history within 1 month before screening, or who received blood transfusion within 2 weeks before screening;
  • Currently using or have used aspirin (> 325 mg/day) or dipyridamole, ticlopidine, clopidogrel, and cilostazol for treatment within 7 days before the first administration of the study drug;
  • Currently using or have used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes within 7 days before the first administration of the study drug. Prophylactic anticoagulation for open intravenous infusion systems is allowed, as long as the drug activity results in an international normalized ratio (INR) < 1.5×upper limit of normal (ULN) and activated partial thromboplastin time (APTT) within the normal range within 14 days before the first administration of the study drug. Prophylactic use of low-molecular-weight heparin (i.e., enoxaparin 40 mg/day) is allowed;
  • Need long-term daily administration of non-steroidal anti-inflammatory drugs (NSAIDs). Occasional use of NSAIDs to relieve medical symptoms such as headache or fever is allowed;
  • Have evidence of intra-abdominal gas that cannot be explained by puncture or recent surgery;
  • Have severe, unhealed or dehisced wounds, active ulcers, or untreated fractures;
  • Have had the following diseases within 6 months before the first administration of the study drug:
  • Abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, and a large amount of ascites as judged by the researcher (defined as patients requiring drainage or treatment within two weeks);
  • Intestinal obstruction and/or have had clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to the original disease or requiring regular parenteral hydration, parenteral nutrition, or tube feeding. Patients with a history of incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms who have improved after treatment can be enrolled as assessed by the researcher;
  • Severe, uncontrollable intra-abdominal inflammation judged by the researcher to require clinical intervention;
  • Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis);
  • Have a known history of psychiatric drug abuse or drug addiction;
  • 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;
  • Currently participating in other clinical studies, or the time between the planned start of treatment in this study and the end of treatment with drugs in the previous clinical study is less than 14 days;
  • Any factors affecting oral administration;
  • Patients deemed inappropriate for inclusion in this study by the researcher.

Trial locations and contacts

1 site in 1 country. 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

China1 site

  • Harbin Medical University Cancer Hosptital

    Harbin

    Yanqiao Zhang, phD, +86 138 4512 0210, yanqiaozhang@ems.hrbmu.edu.cn

Other trials in China

About this study

This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E mutation.

Patients will receive intravenous administration of Aipalolitovorelizumab (QL1706) injection + bevacizumab + oxaliplatin/irinotecan/fluorouracil/calcium folinate, along with oral capecitabine. After completing the corresponding treatment cycles, patients will enter the maintenance treatment phase as determined by the researcher. In the maintenance treatment phase, a 3-week treatment regimen of Aipalolitovorelizumab (QL1706) injection combined with bevacizumab and capecitabine will be adopted, with the administration method and dosage remaining unchanged.

The primary endpoint of this study is objective response rate (ORR); the secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.

Being tested
Aipalolitovorelizumab, XELOX + Bevacizumab, mFOLFOX + Bevacizumab, FOLFOXIRI + Bevacizumab, Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab
Keywords
Colorectal cancer, BRAF V600E mutation, Microsatellite stability, Immunotherapy, First-line treatment
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: 5 mg/kg, intravenous infusion (ivgtt), d1, Q3W;

  • XELOX + BevacizumabDrug

    Bevacizumab 7.5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 130 mg/㎡, intravenous infusion over 2 hours, Day 1; Capecitabine 1000 mg/㎡, oral administration (po), twice a day (bid), Days 1-14. Repeat every 3 weeks.

  • mFOLFOX + BevacizumabDrug

    Bevacizumab 5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 85 mg/㎡, intravenous infusion over 2 hours, Day 1; Calcium Folinate 400 mg/m², intravenous infusion over 2 hours, Day 1; Fluorouracil 400 mg/m², intravenous bolus, Day 1, followed by 1200 mg/(m²·d) continuous intravenous infusion for 2 days (total dose 2400 mg/m², infusion over 46-48 hours). Repeat every 2 weeks.

  • FOLFOXIRI + BevacizumabDrug

    Bevacizumab 5 mg/kg, intravenous infusion, Day 1; Irinotecan 165 mg/m², intravenous infusion, Day 1; Oxaliplatin 85 mg/m², intravenous infusion, Day 1; Calcium Folinate 400 mg/m², intravenous infusion, Day 1; Fluorouracil with a total dose of 2400-3200 mg/m², continuous intravenous infusion over 48 hours on Day 1. Repeat every 2 weeks.

  • Oxaliplatin + Irinotecan + Capecitabine + BevacizumabDrug

    Bevacizumab 7.5 mg/kg, intravenous infusion, Day 1; Oxaliplatin 130 mg/㎡, intravenous infusion over 2 hours, Day 1; Irinotecan 180 mg/m², intravenous infusion over 30-90 minutes, Day 1; Capecitabine 1000 mg/㎡, oral administration (po), twice a day (bid), Days 1-14. Repeat every 3 weeks.

Study groups in NCT07229846
Study groupRoleWhat they receive
Single-arm experimental groupExperimentalNot described
Receives: Drug: Aipalolitovorelizumab; Drug: XELOX + Bevacizumab; Drug: mFOLFOX + Bevacizumab; Drug: FOLFOXIRI + Bevacizumab; Drug: Oxaliplatin + Irinotecan + Capecitabine + Bevacizumab

What is being measured

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

  1. Objective Response Rate

    Defined as the proportion of patients who achieved complete response (CR) andpartial response (PR) according to RECIST v1.1.

    Measured: 6 months

Secondary outcomes (5)

  1. Progression Free Survival

    Defined as the time between signing the informed consent form to the disease progression (according to REClST v1.1 criteria) or death due to any cause

    Measured: 1 year

  2. Disease Control Rate

    Defined as the proportion of patients who achieved complete response (CR),. partiaresponse (PR), and stable disease (SD) according to RECIST V1.1.

    Measured: 6 months

  3. Duration of Response

    Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.

    Measured: 6 months

  4. Overall survival

    Defined as the time between signing the informed consent form to death due tovarious causes.

    Measured: 2 years

  5. Safety

    Use NCI-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 startFeb 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07229846
Sponsor's protocol ID
QL-CRC-QIBA-3006
Status last verified
Jan 2026
First submitted
5 Aug 2025
Last updated
8 Jan 2026
Results posted
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, XELOX + Bevacizumab and mFOLFOX + Bevacizumab in people with Colorectal Cancer, run by Yanqiao Zhang at 1 site in China.

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 15 inclusion and 37 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 NCT07229846.

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 8 Jan 2026.

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