Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Fluorouracil

Cisplatin

Immunoglobulins

EGFR H score ≥ 200, as third-line or above therapy

EGFR H score \<200, as third-line or above therapy

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

HLX07+HLX10+ Cisplatin+5-FU

HLX07

Jing Huang

Wu Zhuang

Feng Ye

Ying wang

Tao Wu

Zhenbo Tan

Ning Li

Zhenyang Liu

Guochun Cao

Lianke Liu

Yuan Yuan

Bo Liu

Junye Wang

Jiayan Chen

Mudan Yang

Jin Zhou

qing Bi

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).

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

An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Objective response rate by IRRC/INV assessment per RECIST

Progression-free survival by IRRC/INV assessment per RECIST

Shanghai Henlius Biotech

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC	NCT05221658	ESCC or Esophag...	HLX07+HLX10+ Ci... HLX07	18 Years - 75 Years	Shanghai Henlius Biotech
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC	NCT05221658	ESCC or Esophag...	HLX07+HLX10+ Ci... HLX07	18 Years - 75 Years	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for escc or esophageal adenosquamous carcinoma