Combined therapy for advanced intrahepatic cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study evaluates the efficacy and safety of a combined therapy using gemcitabine and cisplatin chemotherapy, along with Lenvatinib and Adebrelimab, for patients with advanced and unresectable intrahepatic cholangiocarcinoma. The study targets patients who have limited treatment options due to the aggressive nature of their cancer, which often leads to metastasis and poor survival rates. By integrating chemotherapy with targeted and immunotherapy approaches, the study aims to improve treatment outcomes for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient must be required to sign an informed consent form;
2. Age 18-75 years old, male or female;
3. Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
4. Child-Pugh score A;
5. Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions;
6. Advanced and unresectable ICC patients;
7. The expected survival is longer than 12 weeks;
8. At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1);
9. Functional indicators of vital organs meet the following requirements a Neutrophils ≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; b Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal value(ULN), T3, T4 are in the normal range; c bilirubin ≤ 2 times ULN; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2 times ULN; serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60ml / min;
10. Non-lactating or pregnant women, contraception during or after 3 months of treatment.

Exclusion Criteria:

1. Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other non-cholangiocarcinoma malignant tumor components;
2. Patients who have received previous treatment with PD1 antibody, programmed death ligand -1 （PD-L1） antibody or cytotoxic T lymphocyte-associated antigen-4 （CTLA4） antibody;
3. With other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;
5. Have an active, known or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;
6. Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy;
7. Long-term systemic hormones (dose equivalent to \>10 mg prednisone/day) or any other form of immunosuppressive therapy are required. Subjects using inhaled or topical corticosteroids may be enrolled;
8. Severe cardiopulmonary and renal dysfunction;
9. Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
10. Abnormal blood coagulation (PT\>14s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
11. Hepatitis B virus （HBV） DNA\>2000 copies/ml, hepatitis C virus （HCV） RNA\>1000;
12. Significant clinically significant bleeding symptoms or a clear tendency to appear within 6 months prior to enrollment;
13. Active infections requiring systemic treatment;
14. Human immunodeficiency virus (HIV) positive;
15. History of psychotropic substance abuse, alcohol abuse or drug abuse;
16. Has a history of allergy to platinum;
17. Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.

Where it's running

• Nanfang Hospital of Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jinzhang Chen, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Mengya Zang
• Email: zangmy@163.com
• Phone: 86-20-62787430

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Trastuzumab Rezetecan with Adebrelimab and Lenvatinib for advanced HER2-positive/low-expression biliary tract cancer

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• First-line treatment with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib for advanced HER2-positive or HER2-low biliary tract cancer

  This phase II trial tests whether a combination of Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib can help people with advanced HER2-positive or HER2-low biliary tract cancer respond to treatment as a first line therapy.

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• Combining D-TACE-HAIC with Envafolimab and Lenvatinib for treating advanced liver cancer

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• Treatment for resectable intrahepatic cholangiocarcinoma using a combination of drugs and chemotherapy

  This study is testing a new combination of drugs and chemotherapy to see if it can help people with resectable intrahepatic cholangiocarcinoma live longer and prevent the cancer from coming back after surgery.

  Recruiting Phase 2 Shandong Cancer Hospital and Institute · Jinan, Shandong · NCT06296563

• Combining radiotherapy and immunotherapy for liver cancer with lymph node metastasis

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  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT06261125

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.