Clinical trial NCT06852287: Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Official title: Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma (Icc)
Gall Bladder Cancer
Keywords: GemOX, Lenvatinib, Toripalimab
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Surgical resection rate
timeFrame: through study completion, an average of 1 year
measure: Pathological complete response rate (pCR rate)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tia
Study officials:
References: