A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

• Status: Withdrawn
• Trial end date: 2022-02-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

1. Voluntary participation and written informed consent;

2. Aged 18-75 years (inclusive), males and females;

3. Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;

4. FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;

5. At least one measurable lesion that has not been treated locally;

6. ECOG score of 0-1;

7. Expected survival ≥ 12 weeks;

Exclusion Criteria:

1. Presence of multiple factors affecting oral medications;

2. Wounds unhealed over a long period of time, or fractures not completely healed;

3. Known or suspected allergy to investigational drug or any drug related to this trial.

4. Known cases of CNS(Central Nervous System) metastasis;

5. Uncontrolled cardiac diseases or symptoms;

6. Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;

7. Patients previously treated with FGFR inhibitors (such as erdafitinib)