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

NCT05214222 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-30

No results posted yet for this study

Summary

Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study.

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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • wei wang · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2026-06-02
Completion
2028-09-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214222 on ClinicalTrials.gov