NCCH2213 trial (PLAS trial)

Recruiting

• Conditions: unresectable cutaneous angiosarcoma

• Registration Number: jRCT2031240448

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Study Start: 2025-03-03
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Histologically diagnosed with cutaneous angiosarcoma, and having an unresectable primary or metastatic lesion
2. Having at least one measurable lesion on the body surface that was confirmed by contrast-enhanced CT/MRI or visual inspection within 14 days before enrollment
3. 18 to 85 years old at enrollment
4. With stable blood pressure at 150/90 mmHg or lower within 7 days before enrollment
5. With healed wounds (if any) at enrollment
6. Cooperative with highly effective contraception methods
7. Having given written informed consent

Exclusion Criteria

1. Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, other agents targeting co-inhibitory T-cell receptors, or angiogenesis inhibitors
2. Patients who received chemotherapy or radiotherapy within 28 days before enrollment, or who have not recovered from those toxicities
3. Patients who used other investigational drugs or investigational medical devices within 28 days before enrollment
4. Patients who received live or live attenuated vaccines within 30 days before enrollment
5. Patients with other malignant tumors progressive or requiring aggressive treatment within the past 3 years
6. Patients with active CNS metastasis or carcinomatous meningitis
7. Patients with active autoimmune disease within 2 years before enrollment
8. Patients with clinically significant cardiovascular diseases at NYHA class III or IV within 12 months before enrollment
9. Patients with encasement or invasion of a major blood vessel, or intratumoral cavitation that was diagnosed radiographically within 14 days before enrollment
10. Patients with active infections, gastrointestinal ulcer of Grade 3-4 or fistula, or conditions that might affect gastrointestinal absorption

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		objective response rate (centrally assessed)

Secondary Outcome Measures

Name	Time	Method
Response rate (investigator assessed)		Response rate as assessed by the investigator