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Biliary Tract TumorsPhase 2SpringNCT06892925

QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

A Phase 2 study testing QL1706 in people with Biliary Tract Tumors, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors：A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Tumors
What is being tested?
QL1706
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
14 Jun 2025to Apr 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient voluntarily participates in the trial, provides full informed consent, signs a written consent form, and demonstrates good compliance.
  • The patient is aged 18 or older, regardless of gender.
  • The patient has a histologically confirmed diagnosis of unresectable locally advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder cancer.
  • The patient is newly diagnosed with unresectable locally advanced or metastatic biliary tract cancer and has not received prior systemic therapy.
  • Patients who have previously received radical treatment (surgery, adjuvant chemotherapy, and/or radiotherapy) are allowed, provided disease recurrence is >6 months after treatment. Those who received adjuvant therapy (chemotherapy and/or radiotherapy) and are >6 months post-treatment are also eligible.
  • At baseline, the patient has at least one measurable lesion according to RECIST v1.1 that can be repeatedly and accurately measured.
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  • The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.
  • The patient has an expected survival of ≥12 weeks.
  • The patient has adequate organ and bone marrow function, meeting the following criteria (within 14 days before starting study treatment):
  • Hematology (no transfusions, granulocyte colony-stimulating factor [G-CSF], or corrective medications within 14 days of screening): Hemoglobin (Hb) ≥90 g/L; Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; Platelets (PLT) ≥75×10⁹/L.
  • Biochemistry (no albumin transfusion within 14 days of screening): Total bilirubin (BIL) ≤2×upper limit of normal (ULN) (≤3×ULN for Gilbert's syndrome patients); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3.0×ULN (≤5×ULN for liver metastases patients); Serum creatinine (Cr) ≤1.5×ULN or endogenous creatinine clearance rate ≥50 ml/min (Cockcroft-Gault formula).
  • For males: Cr clearance = ((140 - age) × weight) / (72 × serum Cr)
  • For females: Cr clearance = ((140 - age) × weight) / (72 × serum Cr) × 0.85 (weight in kg; serum Cr in mg/mL).
  • HBV-infected patients (HBsAg and/or anti-HBc positive) with detectable HBV DNA (≥10 IU/mL or above local laboratory detection limit) must receive antiviral therapy before study drug administration, as per institutional practice, to ensure viral suppression. They must continue antiviral therapy during the study and for 6 months after the last dose. Anti-HBc-positive patients without detectable HBV DNA (<10 IU/mL or below detection limit) do not require antiviral therapy unless HBV DNA exceeds 10 IU/mL or the local laboratory detection limit during the study.
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first dose.
  • Women of childbearing potential engaging in sexual activity with non-sterilized males must use acceptable contraception from screening until 120 days after the last study drug dose.
  • Non-sterilized male patients engaging in sexual activity with women of childbearing potential must use effective contraception from screening until 120 days after the last dose. Contraception cessation after this period should be discussed with the investigator.
  • The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.

Who cannot join

  • Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors.
  • Subjects with other malignancies within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been cured.
  • History of leptomeningeal carcinoma, brain metastasis.
  • Participation in another interventional clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.
  • Any disease evidence deemed by the investigator to disqualify the subject, such as uncontrolled hypertension, active bleeding disorder, active infection, active interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, psychiatric illness, or social condition, or a history of allogeneic organ transplantation.
  • Severe cardiovascular disease history: NYHA Class II or above heart failure, unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months before drug administration; echocardiogram showing LVEF <50%; QTc >480ms (Fridericia method, average of three consecutive measurements 2 minutes apart if QTc is abnormal); poorly controlled hypertension (systolic BP ≥150 mmHg and/or diastolic BP ≥100 mmHg, based on the average of ≥2 measurements); history of hypertensive crisis or encephalopathy.
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  • Active autoimmune disease within the past 2 years or a history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (excluding patients controlled by hormone replacement therapy).
  • Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1, CTLA-4, TIGIT, LAG3 antibodies), immune checkpoint agonists (e.g., CD40, CD137, OX40 antibodies), or other immunotherapy for tumor immune mechanisms, except therapeutic antitumor vaccines.
  • Co-infection with HBV (HBsAg and/or anti-HBcAb positive with detectable HBV DNA) and HCV (anti-HCV antibody positive), or HBV and HDV (anti-HDV antibody positive).
  • Severe peptic ulcer, gastritis, gastrointestinal perforation, abdominal fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months before first dose; acute exacerbation of COPD within 1 month before first dose.
  • Life-threatening bleeding event within 3 months before first study drug administration, including those requiring transfusion, surgery, local treatment, or ongoing medication.
  • Major surgery or severe trauma within 30 days before first dose, or planned major surgery within 30 days after first dose (investigator's decision); minor local surgery within 3 days before first dose (excluding central venous catheter placement and venous port implantation).
  • Pregnant or breastfeeding women; men or women of reproductive potential unwilling to use effective contraception from screening until 90 days after last study intervention dose or 180 days after last investigational drug dose.
  • Known allergy or hypersensitivity to any study intervention or its excipients.
  • Other patients deemed unsuitable for inclusion by the treating physician.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the Third Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai Municipality, 200433/201805

Other trials in China

About this study

Official title: QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors: A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)

QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors：A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)

Read the detailed description

This open - label, prospective, single - arm, multicenter phase II clinical study aims to assess the efficacy and safety of QL1706 combined with lenvatinib and GEMOX as first - line treatment for patients with unresectable biliary tract tumors.

Being tested
QL1706
Keywords
QL1706, Lenvatinib, GEMOX, First - Line Treatment

What participants receive

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

  • QL1706Drug

    Also called Lenvatinib, GEMOX

    Eligible participants will receive QL1706 at 5.0 mg/kg intravenously every 3 weeks, lenvatinib at 8 mg orally once daily every 3 weeks, oxaliplatin at 85 mg/m², and gemcitabine at 1000 mg/m² (on days 1 and 8 of each cycle) for up to 8 cycles. Then, they will continue with QL1706 and lenvatinib until clinical progression, imaging progression per RECIST 1.1, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met.

Study groups in NCT06892925
Study groupRoleWhat they receive
Arm 1ExperimentalQL1706 Combined with Lenvatinib and GEMOX
Receives: Drug: QL1706

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: Up to approximately 4 years

Secondary outcomes (10)

  1. Disease Control Rate (DCR)

    DCR was assessed by investigators per RECIST 1.1

    Measured: Up to approximately 4 years

  2. Time to Response (TTR)

    TTR was assessed by investigators per RECIST 1.1

    Measured: Up to approximately 4 years

  3. Duration of Response (DOR)

    DOR was assessed by investigators per RECIST 1.1

    Measured: Up to approximately 4 years

  4. Progression-free Survival (PFS)

    PFS was assessed by investigators per RECIST 1.1

    Measured: Up to approximately 4 years

  5. 12months-PFS rate

    12months-PFS rate was assessed by investigators per RECIST 1.1

    Measured: 12 months

  6. 6months-PFS Rate

    6months-PFS Rate was assessed by investigators per RECIST 1.1

    Measured: 6 months

  7. Overall Survival (OS)

    OS was defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 4 years

  8. 12months-OS Rate

    12months-OS Rate was assessed by investigators per RECIST 1.1

    Measured: 12 months

  9. 24months-OS Rate

    24months-OS Rate was assessed by investigators per RECIST 1.1

    Measured: 24 months

  10. Incidence of Adverse Events (AEs)

    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

    Measured: Up to approximately 4 years

Timeline

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

  1. First posted25 Mar 2025
  2. Study start14 Jun 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2029 (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
Model description
QL1706 combined with lenvatinib and GEMOX
Masking
None (open label)
Enrolment
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06892925
Sponsor's protocol ID
EHBHKY2025-H011-P001
Acronym
Spring
Status last verified
Aug 2026
First submitted
18 Mar 2025
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 in people with Biliary Tract Tumors, run by Eastern Hepatobiliary Surgery Hospital 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 18 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 4 years). 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 NCT06892925.

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 24 Aug 2026.

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