Pemigatinib Combined With PD-1 Inhibitor in Unresectable or Metastatic Intrahepatic Cholangiocarcinoma

NCT05913661 | Unknown Phase 2

• 1 other identifier: SYSKY-2023-061-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Prospective, single-arm, phase II study with multicenter participation. The objective of this study is to evaluate the efficacy and safety of pemigatinib combined with PD-1 inhibitor as first-line treatment for patients with advanced unresectable or metastatic intrahepatic cholangiocarcinoma.

Conditions

Carcinoma; Intrahepatic Cholangiocarcinoma; Digestive System Neoplasms; PD-1 Inhibitor; First-line Treatment

Keywords

unresectable intrahepatic cholangiocarcinoma; metastatic intrahepatic cholangiocarcinoma; first-line treatment; Pemigatinib; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of subjects who achieved complete response (CR; all target lesions disappeared) or partial response (PR; the sum of the longest diameter of target lesions decreased by ≥ 30%) according to the RECIST1.1 standard.

  2 years

Secondary Outcomes (4)

• Progression-Free-Survival

  2 years

• Duration of Response

  2 years

• Disease Control Rate

  2 years

• Overall Survival

  2 years

Study Arms (1)

pemigatinib combined with PD-1 inhibitor

EXPERIMENTAL

pemigatinib combined with PD-1 inhibitor as first-line treatment within advanced unresectable or metastatic intrahepatic cholangiocarcinoma

Drug: Pemigatinib; Drug: PD-1 Inhibitors

Interventions

Pemigatinib DRUG

Pemigatinib is scheduled to be administered at a dose of 13.5 mg quaque die according to a 2-week dosing and 1-week discontinuation regimen.

Also known as: Pemazyre

pemigatinib combined with PD-1 inhibitor

PD-1 Inhibitors DRUG

The dosing regimen is 200 mg IV Q3W

Also known as: Sintilimab

pemigatinib combined with PD-1 inhibitor

Eligibility Criteria

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

You may qualify if:

• Local advanced, recurrent, or metastatic cholangiocarcinoma confirmed by histology or cytology and judged as unresectable by imaging and clinical diagnosis;
• Have not received systematic treatment in the past;
• The existence of FGFR2 fusion/rearrangement was confirmed by gene detection;
• Male or female aged ≥ 18 years;
• According to RECIST v1.1, there is at least one measurable target lesion. And the target lesion has not received local treatment;
• No other anti-tumor treatment was received within 4 weeks before the first use of the study drug;
• Life expectancy ≥ 12 weeks;
• Eastern Oncology Collaboration group (ECOG) physical condition (PS) score 0-1;
• Having sufficient organ and bone marrow function reserve, which is defined as follows:(1)Absolute neutrophil count (ANC) ≥ 1.5 × 109/L Platelet count (PLT) ≥ 80 × 109/L Hemoglobin content (HGB) ≥ 9.0 g/dL. G-CSF, GM-CSF, red blood cell infusion, and platelet infusion were not used within 14 days before the examination; (2)Liver function requirement for patients without liver metastasis: serum total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Requirements for patients with liver metastasis or intrahepatic cholangiocarcinoma: serum TBIL ≤ 1.5 × ULN; ALT and AST ≤ 5 × ULN; (3)Renal function: creatinine clearance rate (Ccr) ≥ 50 mL/min (calculated by Cockcroft/Default formula): female: CrCl=(0.85 × (140 - Age) × (Weight)/(72 × Serum creatinine (mg/dL), male: CrCl=(140 age) × (Weight)/(72 × Serum creatinine (mg/dL); (4)Sufficient blood coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If the subject is receiving anticoagulation treatment, it is acceptable as long as PT is within the scope of anticoagulation drugs;
• Female subjects of reproductive age or male subjects with female sexual partners of reproductive age shall take effective contraceptive measures during the whole treatment period and 6 months after the treatment period.

You may not qualify if:

• Previously received selective FGFR inhibitor treatment, excluding pan target inhibitors such as Anlotinib and Lenvatinib
• Received immunosuppressive drugs within 4 weeks before the first administration of the trial treatment, excluding local glucocorticoids or systemic glucocorticoids of physiological dose by nasal spray, inhalation, or other means (i.e. no more than 10 mg/day prednisone or other glucocorticoids of equivalent dose).
• Received live attenuated vaccine within 4 weeks before the first administration of the trial treatment or during the study period.
• Received any other study drug treatment or participated in interventional clinical research 4 weeks before the first administration of the trial treatment;
• Before the first administration of the trial treatment, there was toxicity caused by previous anti-tumor treatment that was not restored to the level 0 or 1 of the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 (NCI CTCAE Version 5.0) (excluding alopecia, non-clinically significant laboratory abnormalities, and asymptomatic laboratory abnormalities).
• Active, known or suspected autoimmune disease, or history of autoimmune disease in the past 2 years (patients with vitiligo that do not need systematic treatment, psoriasis, alopecia, or Graves' disease in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy and type I diabetes who only need insulin replacement therapy can be enrolled).
• Known history of primary immunodeficiency.
• Known to have active pulmonary tuberculosis.
• Known Symptomatic central nervous system metastases and/or carcinomatous meningitis. For patients with brain metastasis who have received treatment in the past, if their condition is stable (no evidence of imaging progress is found at least 4 weeks before the first administration of the trial treatment), and repeated imaging examination proves that there is no evidence of new brain metastasis or enlargement of the original brain metastasis focus, and they do not need steroid treatment at least 14 days before the first administration of the trial treatment, they can participate in the trial. This exception does not include carcinomatous meningitis, regardless of its clinical stability should be excluded.
• Medical history of other primary malignant tumors, except: (1)malignant tumors that have completely alleviated for at least 5 years before enrollment and do not require other treatment during the study period; (2)Fully treated non-melanoma skin cancer or malignant lentigo without evidence of disease recurrence; (3)Fully treated carcinoma in situ without evidence of disease recurrence.
• During pregnancy or lactation.
• Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• The following abnormal laboratory parameters: (1) Serum phosphate \> ULN, and considered clinically significant by the investigator; (2) Serum calcium \> ULN, or when serum albumin exceeds the normal range, the corrected calcium concentration of serum albumin exceeds the normal upper limit.
• Known history of human immunodeficiency virus (HIV) infection or confirmed positive immune test result.
• Known active serious infections or poorly clinically controlled infections.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• First Affiliated Hospital of Jinan University: collaborator
• Shenzhen University General Hospital: collaborator

Study Sites (1)

Lei Zhang

Guangzhou, Guangdong, 510220, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Cholangiocarcinoma; Digestive System Neoplasms

Interventions

pemigatinib; Immune Checkpoint Inhibitors; sintilimab

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms by Site; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Lei Zhang, PHD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, PHD

CONTACT

86-136-0273-0646; zhangl9@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)