Combining Durvalumab with GemCis for treating resectable intrahepatic cholangiocarcinoma

Duvalumab Combined With GemCis Neoadjuvant Therapy of Resectable Intrahepatic Cholangiocarcinoma With High Recurrence Risk, Phase II, Single Center, Randomized Controlled Study

This study is testing if a new combination of Durvalumab with Gemcitabine and Cisplatin can help patients with resectable intrahepatic cholangiocarcinoma avoid cancer recurrence before their surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: Durvalumab
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05672537 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of Durvalumab in combination with Gemcitabine and Cisplatin as a neoadjuvant therapy for patients with resectable intrahepatic cholangiocarcinoma (ICC) who are at high risk for recurrence. The study is randomized and controlled, aiming to determine if this combination can improve outcomes compared to standard treatment. Participants will undergo this treatment before surgical resection of their tumors. The trial focuses on patients with specific tumor characteristics that indicate a higher likelihood of recurrence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of resectable intrahepatic cholangiocarcinoma and specific tumor characteristics indicating high recurrence risk.

Not a fit: Patients who have previously received systemic treatment for their cancer or have severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in patients with intrahepatic cholangiocarcinoma.

How similar studies have performed: While the combination of immunotherapy and chemotherapy is being explored in various cancers, this specific approach for intrahepatic cholangiocarcinoma is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18, male or female;
2. Pathological diagnosis confirmed intrahepatic cholangiocarcinoma, which could be resected surgically; One of the following conditions shall be met:

   2.1 Single tumor, diameter greater than 5cm (T1b) 2.2 Single tumor with vascular invasion (T2), multiple tumors ≤ 3 2.3 Tumor penetrating visceral peritoneum (T3) or directly invading surrounding organs (T4) 2.4 Suspicious lymph node metastasis in Zone 8, 12 or 13
3. Can not received systemic treatment before participating in the study;
4. ECOG PS score 0-1;
5. The main organs function normally, and there is no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.
6. Laboratory inspection shall meet the following requirements:

   Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.
7. The patient voluntarily participated and signed the informed consent form;
8. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the requirements of the scheme.

Exclusion Criteria:

1. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 before enrollment, or directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, 0X40, CD137);
2. Any other research drugs within 4 weeks before enrollment;
3. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);
4. Congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection;
5. Uncontrollable clinical cardiac symptoms or diseases, such as NYHA II and above heart failure unstable angina pectoris, myocardial infarction within one year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
6. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\>38.5 ° C occurred during screening/before the first drug administration;
7. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
8. Live attenuated vaccine shall be inoculated within 4 weeks before the first administration or planned during the study period;
9. Suffered from or accompanied by other system malignant tumors in the last 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
10. Allergic to any test drug;
11. Pregnant and lactating women, fertile subjects are unwilling to take effective contraceptive measures;
12. Uncontrollable psychosis;
13. Other situations that the researcher thinks are not suitable for inclusion. If the patient has central nervous system metastasis, has serious laboratory examination abnormalities, and is accompanied by family or social factors, it will affect the safety of the subject, or the collection of data and samples.

Where this trial is running

Tianjin, Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin, China (Recruiting)

Conditions Durvalumab; Intrahepatic Cholangiocarcinoma; Gemcis