Combined therapy for advanced intrahepatic cholangiocarcinoma

Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: a Prospective, Single-arm, Phase II Trial.

This study is testing a new combination of chemotherapy and targeted therapy to see if it can help people with advanced bile duct cancer feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Drugs / interventions: prednisone, Adebrelimab, Lenvatinib, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06298968 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histopathologically confirmed advanced and unresectable intrahepatic cholangiocarcinoma.

Not a fit: Patients with resectable intrahepatic cholangiocarcinoma or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly extend survival and improve quality of life for patients with advanced intrahepatic cholangiocarcinoma.

How similar studies have performed: While the combination of chemotherapy and targeted therapies has shown promise in other cancers, this specific approach for intrahepatic cholangiocarcinoma is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Guangzhou, Guangdong

• 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

Conditions: Intrahepatic Cholangiocarcinoma, Lenvatinib, Adebrelimab, gemcitabine, cisplatin