RecruitingPhase 2NCT05214222

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

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

100 participants

Start Date

Sep 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — penpulimab (immunotherapy), chemotherapy (paclitaxel and cisplatin), and anlotinib (a targeted therapy that blocks blood vessel growth) — for people with advanced or metastatic esophageal squamous cell carcinoma who have not previously received systemic treatment. **You may be eligible if...** - You have stage III–IV esophageal squamous cell carcinoma that cannot be cured with surgery or radiation - You have not previously received systemic treatment, or your prior treatment was completed at least 6 months ago - You are between 18 and 75 years old - You have at least one measurable tumor - You are in good enough physical condition (ECOG score of 0–1) - Your organ function meets the required levels **You may NOT be eligible if...** - Your esophageal cancer is completely obstructed and requires intervention to open the passageway - Your tumor is causing a connection between the esophagus and airway (fistula) - You have previously received immunotherapy or anti-angiogenic treatment - You have serious heart disease, uncontrolled high blood pressure, or active bleeding - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib/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

DRUGPenpulimab/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.


Locations(1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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NCT05214222


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