Low-dose Gemcitabine and Cisplatin and PD-1/PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma

NCT06567600 | Not Yet Recruiting Phase 2

• 1 other identifier: ZSSY-2407
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1/PD-L1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma.

Conditions

Intrahepatic Cholangiocarcinoma; Chemotherapy Effect; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR according to RECIST 1.1 using investigator assessment

  12 months

Secondary Outcomes (5)

• Incidence of adverse events

  12 months

• Deepness of response (DpR)

  12 months

• Disease control rate (DCR)

  12 months

• Overall Survival (OS)

  36 months

• Progression-free Survival (PFS)

  36 months

Study Arms (1)

Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody

EXPERIMENTAL

Low-dose Gemcitabine and Cisplatin Chemotherapy: Gemcitabine 500 mg/m2 Cisplatin 12.5 mg/m2 on day 1 and day 8 of each 21-day cycle for up to eight cycles PD-1/PD-L1Antibody: Pembrolizumab 200mg on day 1 of each 21-day cycle Durvalumab 1500 mg on day 1 of each 21-day cycle After completion of gemcitabine and cisplatin, 200mg of Pembrolizumab or 1500 mg of Durvalumab may administer once every 3 or 4 weeks until clinical or imaging (per RECIST v1.1) disease progression or until unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria were met.

Drug: Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody

Interventions

Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody DRUG

Low-dose Gemcitabine and Cisplatin Chemotherapy: Gemcitabine 500 mg/m2 Cisplatin 12.5 mg/m2 on day 1 and day 8 of each 21-day cycle for up to eight cycles PD-1/PD-L1Antibody: Pembrolizumab 200mg on day 1 of each 21-day cycle Durvalumab 1500 mg on day 1 of each 21-day cycle After completion of gemcitabine and cisplatin, 200mg of Pembrolizumab or 1500 mg of Durvalumab may administer once every 3 or 4 weeks until clinical or imaging (per RECIST v1.1) disease progression or until unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria were met.

Also known as: LDGC-PB

Low-dose Gemcitabine and Cisplatin Chemotherapy plus PD-1/PD-L1Antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, male or female;
• Histopathologically confirmed intrahepatic cholangiocarcinoma;
• TNM Staging≥Stage II (American Joint Committee on Cancer Prognostic Groups)
• Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Child-Pugh score ≤ 7;
• Adequate organ function (neutrophil count of ≥1.5×10\^9 cells/L, hemoglobin concentrations of ≥90 g/L, platelet cell count of ≥100×10\^9 cells/L, bilirubin ≤1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5×ULN, serum creatinine ≤ 1.5 x ULN, Thyroid stimulating hormone (TSH) ≤ 1 x ULN;
• The patient must be required to sign an informed consent form;

You may not qualify if:

• Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;
• Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
• 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;
• Active infection requiring systemic therapy;
• Human immunodeficiency virus (HIV) positive;
• 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;
• Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• Abnormal blood coagulation (INR \>1.5, or PT\>ULN+4s, or APTT \>1.5 x ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy;
• Pregnant or lactating women;
• Participated in other trials within the last 4 weeks;
• Has a history of allergy to platinum;
• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ye Linsen, Professor

  The third affiliated hospital of SYSU

  STUDY CHAIR

Central Study Contacts

Ye Linsen

CONTACT

+86 17502060927; ye_linsen@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: low-dose gemcitabine and cisplatin combined with PD-1/PD-L1 inhibitors

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

CN (1)