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A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC

NCT05221658 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-29

No results posted yet for this study

Summary

This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score \< 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Conditions

  • ESCC or Esophageal Adenosquamous Carcinoma

Interventions

DRUG

HLX07+HLX10+ Cisplatin+5-FU

HLX07 1000mg + HLX10 200mg + Cisplatin 50 mg/m2 + 5-FU 2400mg/m2

DRUG

HLX07

HLX07 1000mg iv Q2w

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-08-25
Primary Completion
2024-06-30
Completion
2025-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT05221658 on ClinicalTrials.gov