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NCT Number: NCT07787273

Interferon Gamma Plus Camrelizumab as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

This study aims to evaluate the efficacy and safety of interferon-gamma combined with camrelizumab plus chemotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma. Based on previous mechanistic research and preliminary clinical data, this trial intends to generate high-level evidence for this therapeutic strategy, which may improve the treatment landscape for patients with locally advanced esophageal squamous cell carcinoma.

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Key information

Conditions

Locally Advanced Esophageal Squamous Cell Carcinoma Camrelizumab Neoadjuvant Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hefei Cancer Hospital, Chinese Academy of Sciences, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged >= 18 years;
  • Histologically confirmed esophageal squamous cell carcinoma (ESCC), clinical stage cT1b-3, N+, M0;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Expected overall survival > 6 months;
  • Adequate bone marrow, hepatic, renal, coagulation, and thyroid function.

Exclusion criteria

  • Active autoimmune disease;
  • Requirement for systemic immunosuppressive therapy;
  • Hypersensitivity to any study drug;
  • Uncontrolled significant organ disease (e.g., cardiac, pulmonary, hepatic, renal) or active infection;
  • Pregnant or lactating female.

Treatment and study plan

Interferon-γ

Drug

1,000,000 IU administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.

Camrelizumab

Drug

200 mg administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.

Primary outcomes

  1. Pathological complete response rate

    Time frame: At the time of surgical resection.

    The proportion of patients achieving pathological complete response (absence of viable tumor cells in primary lesion and regional lymph nodes) evaluated by pathological examination of surgical specimens.

Secondary outcomes

  1. Objective Response Rate

    Time frame: At the end of Cycle 2, Cycle 4, (each cycle is 21 days).

    The proportion of participants with confirmed complete response (CR) or partial response (PR) assessed per RECIST 1.1.

  2. Progression-free survival

    Time frame: From date of enrollment until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months.

    Time from enrollment to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.

  3. Overall Survival

    Time frame: From date of enrollment until death from any cause, assessed up to 24 months.

    Follow-up via outpatient visits or telephone interviews; defined as time from enrollment to death from any cause.

  4. Duration of Response

    Time frame: From the date of first documented confirmed response until disease progression or death from any cause, assessed up to 24 months.

    Time from first observation of confirmed CR or PR to disease progression or death from any cause, assessed per RECIST Version 1.1.

Other outcomes

  1. Adverse events

    Time frame: Baseline up to 90 days after last study treatment.

    Adverse events graded by CTCAE Version 5.0; safety follow-up within 90 days after last study drug administration to monitor outcomes of adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongzhi Wang

CONTACT

[email protected]

+86 551 6589 5180

Sponsors and collaborators

Lead sponsor

Hefei Cancer Hospital of the Chinese Academy of Sciences

Network

Registry information

Official study title

Study of Efficacy and Safety of Interferon Gamma Combined With Camrelizumab for Neoadjuvant Therapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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