Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07481058

KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer

Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2026-03-20

60

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

CONDITIONS

Official Title

KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged 18 to 75 years
  • Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma
  • No prior systemic anti-tumor therapy for current recurrent or metastatic disease
  • At least one measurable tumor lesion according to RECIST 1.1
  • Eastern Cooperative Oncology Group performance status score of 0 or 1
  • Life expectancy greater than 12 weeks
  • Body Mass Index (BMI) of at least 16.0 kg/m2
  • Adequate bone marrow, kidney, and liver function
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before the first dose
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis
  • Other malignancies within the past 5 years
  • Known allergies to monoclonal antibodies or chemotherapy components
  • Gastrointestinal abnormalities
  • High risk of bleeding or fistula due to tumor invasion or existing esophageal/tracheal fistula
  • Cardiovascular or cerebrovascular diseases
  • Prior treatment with anti-angiogenic drugs or immunotherapy
  • Systemic therapy, investigational drugs, or live vaccines within 4 weeks before first dose
  • Palliative radiotherapy within 2 weeks or major surgery within 28 days before enrollment
  • Uncontrolled pleural effusion, pericardial effusion, or ascites needing repeated drainage
  • Unresolved toxicities from prior anti-tumor therapy above Grade 1
  • Active autoimmune disease or history requiring systemic treatment
  • Active infections including severe infections in past 4 weeks, active tuberculosis, or positive HIV, HBV, or HCV status
  • Pregnant or lactating women
  • Lack of agreement to use contraception during study and for 6 months after
  • Other conditions that increase safety risks or interfere with study results as assessed by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Actively Recruiting

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Research Team

J

Jing Huang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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