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A Single-arm, Multicenter Clinical Study of Iparomlimab and Toripalimab in Combination With Bevacizumab and Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer

ConditionBiliary Tract Cancer (BTC)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXianglin Yuan

About this trial

This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of Iparomlimab and Toripalimab (QL1706) in combination with bevacizumab and chemotherapy as first-line treatment for patients with advanced biliary tract cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent: Patients voluntarily join this study and sign the informed consent form.

Age: 18 to 75 years old, male or female.

Histologically or cytologically confirmed, unresectable locally advanced or metastatic biliary tract cancer (BTC), including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder carcinoma.

No prior systemic anti-tumor therapy for locally advanced or metastatic BTC.

Disqualifiers

Histologically or cytologically confirmed small cell carcinoma, neuroendocrine tumors, lymphoma, sarcoma, colloid carcinoma, adenosquamous carcinoma, squamous cell carcinoma, mucinous intraductal papillary neoplasm, mucinous cystic neoplasms, or other rare pathological types of biliary tract tumors.

Brain Metastases: History of brain metastases or presence of active brain metastases.

Vascular Invasion & Bleeding Risk: Imaging at screening shows tumor invasion or encasement (>180 degrees) of major blood vessels; or the tumor presents with significant necrosis or cavitation, and the investigator judges that enrollment poses a high risk of bleeding.

Cardiac insufficiency classified as Class II or higher according to the New York Heart Association (NYHA) criteria, or Left Ventricular Ejection Fraction (LVEF) < 50% on echocardiography;

Trial design

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Toripalimab

    Drug

    Iparomlimab and Toripalimab (QL1706): 5mg/kg, intravenous (IV), once every 3 weeks (Q3W), Day 1.

  • Bevacizumab

    Drug

    Bevacizumab: 7.5 mg/kg, IV, Q3W, Day 1.

  • Gemcitabine (1000 mg/m2)

    Drug

    Gemcitabine: 1000 mg/m², IV, Q3W, Days 1 and 8

  • Cisplatin

    Drug

    Cisplatin: 25 mg/m², IV, Q3W, Days 1 and 8

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: QL1706 plus bevacizumab and chemotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

6-month progression-free survival rate

The primary endpoint was the 6-month progression-free survival rate

Time frame
From date of enrollment to 6 months

Secondary outcomes

1

Median Progression-Free Survival

Defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.

Time frame
Up to approximately 24 months
2

Objective Response Rate (ORR)

Defined as the proportion of participants with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST 1.1.

Time frame
Up to approximately 24 months
3

Disease Control Rate (DCR)

Proportion of participants achieving a best overall response of CR, PR, or Stable Disease (SD) per RECIST 1.1

Time frame
Up to approximately 24 months
4

Duration of Response (DOR)

Time from the first documented CR or PR to the first documented disease progression or death from any cause.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xianglin Yuan

Lead sponsor

Huazhong University of Science and Technology

Sponsor institution

Source ClinicalTrials.gov
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