NCT05386056

Pembrolizumab and Photodynamic Therapy in Previously Treated Metastatic Esophageal Squamous Cell Carcinoma

A Phase II Study to Explore the Efficacy and Safety of Pembrolizumab and Photodynamic Therapy in Metastatic Esophageal Squamous Cell Carcinoma Failed at Least One Line of Systemic Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 trial investigating the effect and safety of pembrolizumab and photodynamic therapy (PDT) in metastatic esophageal squamous cell carcinoma failed at least one line of systemic treatment. The primary efficacy hypotheses are that the objective response rate (ORR) of combination of PDT and pembrolizumab could be improved compared with pembrolizumab for both primary and metastatic lesions.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
DRUG	Sinoporphyrin Sodium	0.2mg/kg, intravenously on day -2 of cycle 1.
PROCEDURE	Photodynamic therapy	PDT to primary site of ESCC will be given on day -1 of the treatment (24 hours after injection of DVDMS).

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-10-31
• Completion: 2024-06-30
• First posted: 2022-05-23
• Last updated: 2022-11-28

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study