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

ConditionsLocally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant Therapy Camrelizumab

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHefei Cancer Hospital of the Chinese Academy of Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

84 Participants

are divided into 1 treatment group

Group A: Interferon-γ combined with camrelizumab and neoadjuvant chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

At the time of surgical resection.

Secondary outcomes

Objective Response Rate

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

Time frame

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

Progression-free survival

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

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.

Overall Survival

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

Time frame

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

Duration of Response

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

Time frame

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

Other outcomes

Adverse events

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.

Time frame

Baseline up to 90 days after last study treatment.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hefei Cancer Hospital of the Chinese Academy of Sciences

Lead sponsor

Source ClinicalTrials.gov

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