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Biliary Tract Cancer (BTC)Phase 4NCT07619235

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

A Phase 4 study testing Iparomlimab and Toripalimab, Bevacizumab and Gemcitabine (1000 mg/m2) in people with Biliary Tract Cancer (BTC), run by Xianglin Yuan at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer (BTC)
What is being tested?
Iparomlimab and Toripalimab, Bevacizumab and Gemcitabine (1000 mg/m2)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
10 Jun 2026to 31 Dec 2028
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • At least one measurable lesion according to RECIST v1.1 that is suitable for accurate repeated measurement. Lesions previously irradiated or brain metastases are not eligible as target lesions.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
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  • Adequate organ function
  • For HBsAg positive subjects: HBV DNA must be < 2000 IU/mL (or < 10⁴ copies/mL), and effective antiviral therapy (e.g., Entecavir, Tenofovir, TAF, or Tenofovir Amibufenamide) must be administered throughout the study.
  • Subjects with a history of HCV infection but negative HCV RNA PCR results may be considered uninfected.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test (if urine test is not definitively negative, a serum test is required).
  • Willingness to use highly effective contraceptive measures during the study and for 3 months after the last dose.
  • Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other requirements of the study.

Who cannot join

  • 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 Disease: Uncontrolled cardiac clinical symptoms or diseases, including but not limited to:
  • 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;
  • Unstable angina pectoris;
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  • Myocardial infarction within 1 year prior to study entry;
  • Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • QTc interval > 450 ms (male) or > 470 ms (female) (QTc calculated using the Fridericia formula; if abnormal, repeat ECG three times at 2-minute intervals and use the average value).
  • Autoimmune Disease: Active autoimmune disease or a history of autoimmune disease likely to recur (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism [patients controlled solely by hormone replacement therapy are not excluded]).
  • Esophageal/Gastric Varices: History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first dose; known severe varices on endoscopy within 3 months prior to the first dose; or evidence of portal hypertension (including splenomegaly on imaging) with high bleeding risk assessed by the investigator (including moderate-to-severe esophageal/gastric varices with bleeding risk, local active gastrointestinal ulcers, and persistent positive fecal occult blood tests). Endoscopy is required to exclude patients with "red color signs." Patients with a history of "red color signs" are excluded.
  • Hemorrhage: Any life-threatening bleeding event within 3 months prior to the first dose, including events requiring blood transfusion, surgery, local therapy, or continuous medication.
  • Systemic Immunosuppression: Use of systemic corticosteroids or other immunosuppressive therapies for active autoimmune diseases within the past 2 years. Note: Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.
  • Inflammatory Bowel Disease: Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or chronic diarrhea.
  • Transplantation: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Pneumonitis/ILD: Previous or current history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy.
  • Surgery: Major surgical procedure or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator); minor local surgery within 3 days prior to the first dose (excluding peripherally inserted central catheter [PICC] line placement and implantable venous port insertion).
  • Infection: Severe active infection judged by the investigator.
  • Pregnancy: Pregnant women or those planning to become pregnant during the study period.
  • Prior Trials: Participation in another drug clinical trial within 12 months prior to enrollment.
  • Other: Other conditions deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Zhuang Liang Zhuang Liang, 86+13006325115, mrzhuangliang@126.com

    Recruiting

Other trials in China

About this study

Official title: A Study of Iparomlimab and Toripalimab in Combination With Bevacizumab and Chemotherapy as First-line Treatment for Advanced Biliary Tract Cancer

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

Being tested
Iparomlimab and Toripalimab, Bevacizumab, Gemcitabine (1000 mg/m2), Cisplatin
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • Iparomlimab and ToripalimabDrug

    Also called QL1706

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

  • BevacizumabDrug

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

  • Gemcitabine (1000 mg/m2)Drug

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

  • CisplatinDrug

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

Study groups in NCT07619235
Study groupRoleWhat they receive
QL1706 plus bevacizumab and chemotherapyExperimentalIparomlimab/Toripalimab (QL1706) 5 mg/kg IV Q3W (D1); Bevacizumab 7.5 mg/kg IV Q3W (D1); Gemcitabine 1000 mg/m² IV Q3W (D1, D8); Cisplatin 25 mg/m² IV Q3W (D1, D8)
Receives: Drug: Iparomlimab and Toripalimab; Drug: Bevacizumab; Drug: Gemcitabine (1000 mg/m2); Drug: Cisplatin

What is being measured

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

  1. 6-month progression-free survival rate

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

    Measured: From date of enrollment to 6 months

Secondary outcomes (5)

  1. Median Progression-Free Survival

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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: Up to approximately 24 months

  5. Overall Survival (OS)

    Time from enrollment to death from any cause.

    Measured: Up to approximately 36 months

Timeline

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

  1. First posted1 Jun 2026
  2. Study start10 Jun 2026
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion31 Dec 2028 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619235
Sponsor's protocol ID
TJ-IRB202609010
Status last verified
May 2026
First submitted
24 May 2026
Last updated
15 Sep 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 4 study testing Iparomlimab and Toripalimab, Bevacizumab and Gemcitabine (1000 mg/m2) in people with Biliary Tract Cancer (BTC), run by Xianglin Yuan 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 12 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 15 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month progression-free survival rate (time frame: From date of enrollment to 6 months). 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 NCT07619235.

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 15 Sep 2026.

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