Last updated: May 31, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Malignant Pheochromocytoma/paraganglioma
Neuroendocrine Carcinoma
Treatment
Penpulimab
Clinical Study ID
NCT05885399
06086-06
Ages 15-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Provide written informed consent.
- Age 18-75 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Patients with histologically or radiologically confirmed MPP and fail to othersystemic therapy.
- Estimated life expectancy longer than 6 months.
- Confirmed non-pregnancy and lactation. During the entire study period and within 6months after the last administration, the subjects and their spouses are willing touse efficient contraceptive measures.
- Laboratory requirements:
- Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
- Platelet count greater than 80 x 109/L;
- Hemoglobin greater than 90g/L;
- Serum bilirubin less than 1.5 x upper limit of normal (ULN); --)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) lessthan 2.5 x ULN;
- Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lowerlimit of normal value (50%).
Exclusion
Exclusion Criteria:
- Patients who had been previously treated with anti-PD1, anti-PD-L1, or anti-PD-L2medications were excluded from this trial.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 14 days prior to the first dose oftrial treatment.
- Has a known history of active TB (Bacillus Tuberculosis).
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has an active infection requiring systemic therapy.
- Didn't meet eligibility for organ function.
- Abnormal coagulation (INR >1.5 or prothrombin time (PT) > ULN 4 seconds or APTT >1.5ULN), bleeding tendency or being treated with thrombolytic or anticoagulant therapy.
- Uncontrolled congestive heart failure .
Study Design
Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Penpulimab
Phase: 2
Study Start date:
April 01, 2023
Estimated Completion Date:
March 01, 2025
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing,
ChinaActive - Recruiting
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