Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 2, 2022

Primary Completion Date

June 2, 2026

Study Completion Date

September 2, 2028

Conditions
Advanced Esophageal Squamous Cell Carcinoma
Interventions
DRUG

Anlotinib/Penpulimab/Chemotherapy

"Initial treatment (4-6 cycles): Anlotinib, Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin~* Anlotinib: once a day, 1 capsule each time (10mg for body weight \<60KG, 12mg for body weight ≥60KG), d1-d14, 3 weeks as a treatment cycle.~* Penpulimab: 200 mg, d1 per cycle, once every 3 weeks.~* Paclitaxel: According to 135-175mg/m2, intravenous infusion\> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle.~* Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle.~Maintenance treatment: Anlotinib, Penpulimab~* Anlotinib: once a day, 1 capsule each time (the same as the initial treatment dose), take the drug every cycle d1-d14, 3 weeks as a treatment cycle.~* Penpulimab: 200mg, d1 per cycle, once every 3 weeks"

DRUG

Penpulimab/Chemotherapy

"Initial treatment (4-6 cycles): Penpulimab, Paclitaxel or Albumin Paclitaxel,Cisplatin~* Penpulimab: 200 mg, d1 per cycle, once every 3 weeks.~* Paclitaxel: According to 135-175mg/m2, intravenous infusion\> 2h, d1, 3 weeks as a treatment cycle; Albumin paclitaxel: According to 200-260mg/m2, intravenous infusion for 30 minutes, d1, 3 weeks as a treatment cycle.~* Cisplatin: 60-75mg/m2, intravenous infusion, divided into d1-d3 medication per cycle; 3 weeks is a treatment cycle.~Maintenance treatment: Penpulimab~• Penpulimab: 200mg, d1 per cycle, once every 3 weeks Post-progression genetic testing, continued treatment: Anlotinib,Penpulimab Anlotinib: Once daily, one capsule per time (10mg for weight \<60KG, 12mg for weight ≥60KG), administered from day 1 to day 14 of each cycle. Two consecutive weeks of treatment followed by one week off, 3 weeks per treatment cycle.~Penpulimab: 200mg, administered on day 1 of each cycle, every 3 weeks."

Trial Locations (1)

Unknown

RECRUITING

Nanfang Hospital, Southern Medical University, Guangzhou

All Listed Sponsors
lead

Nanfang Hospital, Southern Medical University

OTHER