Phase II Trial Design

Cross-source consensus on Phase II Trial Design from 1 sources and 5 claims.

1 sources · 5 claims

Uses

The study is an investigator-initiated, single-arm, prospective, open-label phase II trial. — Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial
The trial evaluates adjuvant short-course radiotherapy with temozolomide-cisplatin chemotherapy and pucotenlimab in completely resected mucosal melanoma. — Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial
The trial is registered as ChiCTR2400093001 and was registered on 27 November 2024. — Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial
The single-arm open-label design means the study has no randomisation or blinding. — Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial
Recruitment at Fudan University Shanghai Cancer Centre is ongoing with recruitment planned from 1 December 2024 to 1 December 2027. — Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial