NCT07787273

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
29mo left

Started Mar 2026

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 20, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 26, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

August 14, 2026

Last Update Submit

August 21, 2026

Conditions

Locally Advanced Esophageal Squamous Cell CarcinomaNeoadjuvant TherapyCamrelizumab

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response rate

    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.

    At the time of surgical resection.

Secondary Outcomes (4)

  • Objective Response Rate

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

  • Progression-free survival

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

  • Overall Survival

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

  • Duration of Response

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

Other Outcomes (1)

  • Adverse events

    Baseline up to 90 days after last study treatment.

Study Arms (1)

Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy

EXPERIMENTAL
Drug: Interferon-γDrug: Camrelizumab

Interventions

Interferon-γDRUG

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

Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy
CamrelizumabDRUG

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

Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hefei Cancer Hospital, Chinese Academy of Sciences

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

MeSH Terms

Interventions

camrelizumab

Study Officials

  • Hongzhi Wang

    Hefei Cancer Hospital, Chinese Academy of Sciences

    STUDY CHAIR

Central Study Contacts

Hongzhi Wang

CONTACT

+86 551 6589 5180wanghz@hfcas.ac.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2026

First Posted

August 26, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 26, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)