Recruiting

Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

ClinicalTrials.gov IDNCT06852287

PhasePHASE2

Enrollment33

SponsorTianjin Medical University Cancer Institute and Hospital

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Intrahepatic Cholangiocarcinoma (Icc), Gall Bladder Cancer

About this study

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects. 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.

Interventions

Drug: 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.

Primary outcomes

Objective Response Rate (ORR) (through study completion, an average of 1 year)

Eligibility information

Inclusion Criteria 1. Age 18 or above 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: 1. Use any systemic research anti-cancer drugs 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

Study locations

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tia 300060 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.