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New treatment option for Biliary Tract Tumors
Official title QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors
ClinicalTrials.gov ID: NCT06892925
What this study is testing
What is QL1706?
QL1706 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for biliary tract tumors.
Also referred to as Lenvatinib, GEMOX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine...
- people with other malignancies within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that...
- History of leptomeningeal carcinoma, brain metastasis.
- Participation in another treatment clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an...
- Any disease evidence deemed by the investigator to disqualify the subject, such as uncontrolled hypertension, active bleeding disorder, active...
- Severe cardiovascular disease history: NYHA Class II or above heart failure, unstable angina, myocardial infarction, uncontrolled arrhythmia, or...
See the full eligibility criteria
Who can 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...
- At baseline, the patient has at least one measurable lesion according to RECIST v1.1 that can be repeatedly and accurately measured.
- 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)...
- 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...
- 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...
- 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...
- The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.
What rules you out
- Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors.
- people 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 treatment clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-treatment study or the follow-up period of an treatment...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Known allergy or hypersensitivity to any study intervention or its excipients.
- Other patients deemed unsuitable for inclusion by the treating physician.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.