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

NCT05386056 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-11-28

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-10-31
Completion
2024-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT05386056 on ClinicalTrials.gov