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

Last updated: February 25, 2025
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Cancer

Biliary Tract Cancer

Abdominal Cancer

Treatment

chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.

Clinical Study ID

NCT06852287
E20241047
GOLD-HAIC
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria

  1. Age 18 or above

  2. Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma orgallbladder 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 reactionsaccording to the protocol requirements.

Exclusion

Exclusion criteria:

  1. Use any systemic research anti-cancer drugs

  2. Active autoimmune diseases or a history of autoimmune diseases (such as interstitialpneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormonereplacement 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 celltransplantation

  8. Vaccination with attenuated live vaccine within 4 weeks before treatment

  9. Other systemic malignant tumors in the past 5 years

Study Design

Total Participants: 33
Treatment Group(s): 1
Primary Treatment: chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Phase: 2
Study Start date:
September 01, 2024
Estimated Completion Date:
September 01, 2026

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tia 300060
    China

    Active - Recruiting

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