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New treatment option for Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer
Official title Phase II Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Albumin-Bound Paclitaxel and Lenvatinib as Second-Line Therapy for Unresectable or Metastatic Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07530445
What this study is testing
What is Drug: QL1706 5mg/kg, iv drip,d1,Q3W; Albumin-Bound Paclitaxel 125mg/m2, iv drip, d1、d8, Q3W; Lenvatinib 8mg, po, QD?
Drug: QL1706 5mg/kg, iv drip,d1,Q3W; Albumin-Bound Paclitaxel 125mg/m2, iv drip, d1、d8, Q3W; Lenvatinib 8mg, po, QD is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for second-line therapy for unresectable or metastatic biliary tract cancer.
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
- Biliary tract carcinoma (BTC) is a highly aggressive malignancy with rising incidence worldwide. Most patients present at an advanced stage and have a dismal prognosis.
- 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 to 70
You may be able to join if
- people voluntarily agree to participate in the study, sign the informed-consent form, demonstrate good compliance, and are willing to attend...
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary-tract cancer (gallbladder carcinoma...
- Age 18-70 years (inclusive) at the time of informed consent, either male or female.
- ECOG performance status 0-1 and life expectancy ≥ 12 weeks.
- Received one prior line of systemic therapy containing a platinum agent, gemcitabine, or fluoropyrimidine (non-taxane), with or without PD-1/PD-L1...
You likely can't join if
- Known hypersensitivity to any component of the study drugs (QL1706, albumin-bound paclitaxel, or lenvatinib).
- Prior anti-cancer therapy within specified wash-out periods before the first dose of study treatment:
- Fluoropyrimidines (e.g., S-1, capecitabine): ≤ 2 weeks
- Other cytotoxic chemotherapy: ≤ 3 weeks
- Small-molecule targeted therapy: ≤ 2 weeks
- Biologic therapy, large-molecule targeted therapy, or immunotherapy: ≤ 4 weeks
See the full eligibility criteria
Who can join
- people voluntarily agree to participate in the study, sign the informed-consent form, demonstrate good compliance, and are willing to attend follow-up visits.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary-tract cancer (gallbladder carcinoma, cholangiocarcinoma, or ampullary carcinoma of pancreaticobiliary type).
- Age 18-70 years (inclusive) at the time of informed consent, either male or female.
- ECOG performance status 0-1 and life expectancy ≥ 12 weeks.
- Received one prior line of systemic therapy containing a platinum agent, gemcitabine, or fluoropyrimidine (non-taxane), with or without PD-1/PD-L1 antibody.
- Patients who develop distant metastasis after curative-intent surgery are eligible if they received adjuvant chemotherapy without a taxane and relapse \< 6 months after completion of adjuvant therapy.
- At least one measurable lesion according to RECIST v1.1:
- .Lesion diameter ≥ 10 mm on contrast-enhanced MRI or CT.
- .Lesions treated with prior local therapy may be considered measurable if they have progressed and meet RECIST v1.1 criteria.
- .Lesions previously treated with radioactive seed implantation cannot be used as target lesions. 8.No clinically significant cardiovascular, pulmonary, cerebral, or other major organ dysfunction. 9.Adequate Major Organ...
- Hematology White blood cell (WBC) count ≥ 4.0 × 10⁹/L
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count ≥ 75 × 10⁹/L
- Hemoglobin ≥ 80 g/L
- Coagulation
- International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN)
- Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN
- Liver Function
- Total serum bilirubin ≤ 1.5 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN - Patients with concurrent liver metastases may be enrolled if ALT/AST ≤ 5 × ULN
- For obstructive jaundice: serum total bilirubin must be ≤ 1.5 × ULN after adequate internal or external biliary drainage
- Serum albumin ≥ 30 g/L
- Renal Function
- Serum creatinine ≤ 2 × ULN
- Calculated creatinine clearance (CCr) ≥ 40 mL/min (Cockcroft-Gault or equivalent)
- Urinalysis
- Urine protein \< 2+ on dipstick \- If urine protein ≥ 2+, a 24-hour urine collection is required and must show total protein \< 1.0 g to permit enrollment
- Thyroid Function
- Thyroid-stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3) all within ±10 % of the institutional normal range
- Patients with non-autoimmune hypothyroidism whose FT3/FT4 levels are maintained within the normal range on stable replacement therapy are eligible
- If TSH falls outside the above range, FT3, FT4, and clinical status must be assessed; people may be enrolled if findings indicate a non-acute, stable condition
- Cardiac Function
- Left ventricular ejection fraction (LVEF) ≥ 60 % as determined by two-dimensional echocardiography. 10.Contraception requirements
- Women of child-bearing potential must use a medically acceptable contraceptive method (e.g., IUD, oral contraceptive, condom) from screening through 6 months after the last dose of study drug; must have a negative serum...
- Men with partners of child-bearing potential must use effective contraception during the study and for 6 months after the last dose.
What rules you out
- Known hypersensitivity to any component of the study drugs (QL1706, albumin-bound paclitaxel, or lenvatinib).
- Prior anti-cancer therapy within specified wash-out periods before the first dose of study treatment:
- Fluoropyrimidines (e.g., S-1, capecitabine): ≤ 2 weeks
- Other cytotoxic chemotherapy: ≤ 3 weeks
- Small-molecule targeted therapy: ≤ 2 weeks
- Biologic therapy, large-molecule targeted therapy, or immunotherapy: ≤ 4 weeks
- Histologic diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or undifferentiated carcinoma of the biliary tract.
- Obstructive jaundice that has not been adequately relieved (bilirubin not reduced to protocol-specified limits).
- Other malignancies within the past 5 years, except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
- Any history or current evidence of brain metastases.
- Hepatic tumor burden ≥ 70 % of total liver volume, as determined by the investigator.
- Major surgery or invasive procedure within 4 weeks prior to enrollment, unless wound healing is complete (exceptions: venous catheterization, percutaneous drainage, or biliary drainage for obstructive jaundice).
- Loco-regional anti-tumor therapy within 4 weeks, including trans-arterial chemoembolization (TACE), cryoablation, or radiofrequency ablation of liver metastases.
- Clinically significant electrolyte disturbances, as judged by the investigator.
- Uncontrolled hypertension (systolic ≥ 140 mmHg and/or diastolic ≥ 90 mmHg) despite optimal medical management.
- High risk of fatal vascular invasion/bleeding in the opinion of the investigator (e.g., tumor likely to erode a major vessel during the study).
- Bleeding diathesis or significant bleeding history within 3 months, including:
- \> 30 mL bleeding, hematemesis, melena, or hematochezia
- Hemoptysis (\> 5 mL fresh blood within 4 weeks)
- Congenital or acquired coagulopathy
- Clinically relevant hemorrhagic events (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer).
- Clinically significant cardiovascular disease, including:
- Acute myocardial infarction, severe/unstable angina, or coronary artery bypass graft surgery within 6 months
- New York Heart Association (NYHA) class \> II congestive heart failure
- Symptomatic ventricular arrhythmias requiring medication
- QTc interval ≥ 480 ms on ECG.
- Active or uncontrolled severe infection ≥ CTCAE grade 2.
- Persistent toxicity \> CTCAE grade 2 from prior anti-cancer therapy (except alopecia, lymphopenia, or ≤ grade 2 oxaliplatin-related neuropathy). Patients with prior immune-related adverse events that have resolved to...
- Pregnancy (positive pregnancy test) or lactation.
- Any condition that, in the investigator's opinion, would compromise patient safety or data integrity, including:
- Seizure disorder requiring treatment
- Clinically significant metabolic, physical, or laboratory abnormalities
- Any disease state that could interfere with study participation or result in undue risk.
- Known HIV infection or clinically significant chronic liver disease, including:
- Active hepatitis B virus (HBV) infection (HBV DNA \> 1 × 10⁴ copies/mL or \> 2000 IU/mL)
- Hepatitis C virus (HCV) infection with detectable HCV RNA (\> 1 × 10³ copies/mL)
- Other hepatitis, cirrhosis.
- Active or suspected autoimmune disease (e.g., myasthenia gravis, myositis, autoimmune hepatitis, SLE, RA, inflammatory bowel disease, MS, vasculitis, glomerulonephritis, uveitis, hypophysitis). Exceptions may apply for...
- Any social or medical condition (e.g., alcohol or drug abuse, severe psychiatric illness) that, in the investigator's judgment, could interfere with adherence to study procedures, compromise safety, or lead to premature...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.