Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PLUTO)

PHASE2RecruitingINTERVENTIONAL
Enrollment

69

Participants

Timeline

Start Date

December 20, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Renal Cell Carcinoma (RCC)
Interventions
DRUG

Toripalimab

"Preoperative: Toripalimab 240mg, IV on day 1 in a 3-week cycle. Preoperative Toripalimab contains 4-5 cycles.~Postoperative: Toripalimab 240mg, IV on day 1 of a 3-week cycle. Postoperative Toripalimab following surgery within 4 weeks for patients mentioned above in cohort 1, 2 and 3."

DRUG

Lenvatinib

"Preoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Preoperative Lenvatinib contains 4-5 cycles.~Postoperative: Lenvatinib 20 mg orally, QD in a 3-week cycle. Postoperative Lenvatinib following surgery within 4 weeks for patients in cohort 3.~Adjustment of dose: For patients with intolerable adverse reactions (CTCAE v5.0 grade 3 or grater), the dose could be reduced to 12mg for those who were suitable to continue taking the drug after systematic evaluation by the investigator. Patients who are assessed as intolerable and not suitable for continued medication will discontinue and undergo nephrectomy within 4 weeks."

Trial Locations (1)

210000

RECRUITING

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China, Nanjing

All Listed Sponsors
lead

Jinling Hospital, China

OTHER