Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
NCT ID: NCT06852287
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
33 participants
INTERVENTIONAL
2024-09-01
2026-09-01
Brief Summary
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This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GemOX hepatic arterial infusion combined with lenvatinib and Toripalimab
Triprolizumab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd); Chemotherapy hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
Interventions
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chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
Eligibility Criteria
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Inclusion Criteria
2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
3. A tumor that cannot be removed by three independent surgeons.
4. Expected lifespan ≥ 12 weeks
5. ECOG PS score 0-1 points
6. The patient voluntarily participates and signs an informed consent form;
7. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.
Exclusion Criteria
2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
3. Asthma requires the use of bronchodilators for medical intervention
4. Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
5. Clinical symptoms or uncontrolled heart disease
6. Severe infection within 4 weeks before the first use of medication
7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
8. Vaccination with attenuated live vaccine within 4 weeks before treatment
9. Other systemic malignant tumors in the past 5 years
18 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Wei Zhang
Surgical chief physician & Deputy Director of Hepatobiliary Oncology Department
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tia, China
Countries
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Central Contacts
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Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer
Role: CONTACT
Phone: 86-2223340123
Email: [email protected]
wei zhang, surgical chief physician, M.D., Ph.D.
Role: CONTACT
Phone: 8618622025401
Email: [email protected]
Facility Contacts
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Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer
Role: primary
Other Identifiers
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GOLD-HAIC
Identifier Type: OTHER
Identifier Source: secondary_id
E20241047
Identifier Type: -
Identifier Source: org_study_id