Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalim… (NCT06852287) | Clinical Trial Compass
RecruitingPhase 2
Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
China33 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 or above
✓. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
✓. A tumor that cannot be removed by three independent surgeons.
✓. Expected lifespan ≥ 12 weeks
✓. ECOG PS score 0-1 points
✓. The patient voluntarily participates and signs an informed consent form;
✓. Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.
Exclusion criteria
✕. Use any systemic research anti-cancer drugs
✕. 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)
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: through study completion, an average of 1 year
Trial details
NCT IDNCT06852287
SponsorTianjin Medical University Cancer Institute and Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-09-01
Contact for this trial
Tianjin Medical University Cancer Institute and Hospital Department of Hepatobiliary Cancer