Actively Recruiting
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
Led by Sun Yat-sen University · Updated on 2026-04-15
40
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. First-line gemcitabine-platinum plus PD-1/PD-L1 blockade has become the new standard, yet no established second-line therapy exists after progression on this regimen. Combining dual checkpoint inhibition (PD-1/CTLA-4) with anti-angiogenic therapy and chemotherapy may overcome primary resistance.Although several studies have evaluated immune-checkpoint inhibitors (ICIs) alone or combined with anti-angiogenic agents in advanced BTC, overall survival improvements remain modest, and enrolled patients have typically progressed after chemotherapy only. Thus, the optimal second-line regimen in the immunotherapy era-especially the efficacy and safety of combining ICIs with chemotherapy-warrants further investigation.Dual PD-1/PD-L1 plus CTLA-4 blockade can comprehensively reactivate anti-tumor immunity by relieving T-cell suppression and enhancing cytotoxic function. QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability. Lenvatinib is a multi-target tyrosine-kinase inhibitor with anti-angiogenic and immunomodulatory properties.For patients progressing after first-line therapy, preliminary data indicate that combining ICIs with anti-angiogenic agents (VEGFR2 antibodies or TKIs) yields modest efficacy; however, prospective evidence-especially for those refractory to chemotherapy plus PD-1/PD-L1 inhibitors-is lacking. Therefore, we designed an exploratory clinical trial evaluating QL1706 combined with albumin-bound paclitaxel and lenvatinib as second-line treatment for unresectable or metastatic BTC, aiming to provide a safe and effective option, particularly for patients previously exposed to PD-1/PD-L1 inhibitors, to prolong survival and improve quality of life.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily agree to participate and sign informed consent.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer.
- Age between 18 and 70 years inclusive.
- ECOG performance status of 0 or 1 and life expectancy of at least 12 weeks.
- Received one prior line of systemic therapy containing platinum, gemcitabine, or fluoropyrimidine (non-taxane), with or without PD-1/PD-L1 antibody.
- Patients with distant metastasis after curative surgery are eligible if relapse occurred within 6 months after completing adjuvant chemotherapy without taxane.
- At least one measurable lesion according to RECIST v1.1 criteria.
- No clinically significant cardiovascular, pulmonary, cerebral, or other major organ dysfunction.
- Adequate major organ and bone marrow function as defined by specific laboratory values.
- Women of child-bearing potential must use contraception and have a negative pregnancy test; men must use effective contraception.
You will not qualify if you...
- Known allergies to QL1706, albumin-bound paclitaxel, or lenvatinib.
- Recent anticancer therapy within specified washout periods (fluoropyrimidines ≤ 2 weeks, other chemotherapy ≤ 3 weeks, targeted therapy ≤ 2 weeks, biologics or immunotherapy ≤ 4 weeks).
- Histologic diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or undifferentiated carcinoma of the biliary tract.
- Unrelieved obstructive jaundice.
- Other cancers within the past 5 years except treated basal-cell or squamous-cell skin cancer or cervical carcinoma in situ.
- History or current brain metastases.
- Hepatic tumor burden ≥ 70% of liver volume.
- Major surgery or invasive procedure within 4 weeks prior to enrollment unless healing is complete.
- Recent loco-regional anti-tumor therapy within 4 weeks.
- Clinically significant electrolyte disturbances.
- Uncontrolled hypertension despite treatment.
- High risk of fatal vascular invasion or bleeding.
- Significant bleeding history within 3 months.
- Significant cardiovascular disease including recent myocardial infarction or severe heart failure.
- Active or uncontrolled severe infection.
- Persistent toxicity > grade 2 from prior therapy except specified exceptions.
- Pregnancy or breastfeeding.
- Conditions compromising safety or study participation.
- Known HIV infection or significant chronic liver disease.
- Active or suspected autoimmune diseases except controlled conditions.
- Social or medical conditions interfering with adherence or safety.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhiqiang Wang, guangzhou, Other (Non U.S.) 510000 Recruiting
Guangzhou, China
Actively Recruiting
Research Team
Z
Zhiqiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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