Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT07787273
Interferon Gamma Plus Camrelizumab as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Interferon-γ and Camrelizumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Hefei Cancer Hospital of the Chinese Academy of Sciences at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy, Camrelizumab
- What is being tested?
- Interferon-γ and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesChina
- Study dates
- 20 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Hefei Cancer Hospital, Chinese Academy of Sciences
Hefei, Anhui
Hongzhi Wang, +86 551 6589 5180, wanghz@hfcas.ac.cn
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Huaguang Pan, 15776762369, 68618385@qq.com
About this study
Official title: Study of Efficacy and Safety of Interferon Gamma Combined With Camrelizumab for Neoadjuvant Therapy in Patients With 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.
- Being tested
- Interferon-γ, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-γDrug
1,000,000 IU administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.
CamrelizumabDrug
200 mg administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy | Experimental | Not described Receives: Drug: Interferon-γ; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgical resection.
Secondary outcomes (4)
Objective Response Rate
The proportion of participants with confirmed complete response (CR) or partial response (PR) assessed per RECIST 1.1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the date of first documented confirmed response until disease progression or death from any cause, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start20 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hefei Cancer Hospital of the Chinese Academy of Sciences
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hongzhi Wang, Study chair, Hefei Cancer Hospital, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787273
- Sponsor's protocol ID
- PJ-KY2025-061
- Status last verified
- Jul 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of Interferon Gamma Combined With Camrelizumab for Neoadjuvant Therapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07787273
- Acronym / sponsor ID
- PJ-KY2025-061
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hefei Cancer Hospital of the Chinese Academy of SciencesResearch network
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy | Experimental | Drug: Interferon-γ, Drug: Camrelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-γ1,000,000 IU administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles. | Drug | Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy |
| Camrelizumab200 mg administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles. | Drug | Interferon-γ combined with camrelizumab and neoadjuvant chemotherapy |
Primary outcome
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.
4 secondary outcomes
Objective Response Rate
Time frame: At the end of Cycle 2, Cycle 4, (each cycle is 21 days).
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.
Overall Survival
Time frame: From date of enrollment until death from any cause, assessed up to 24 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongzhi Wang study chair
Hefei Cancer Hospital, Chinese Academy of Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon-γ and Camrelizumab in people with Locally Advanced Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Hefei Cancer Hospital of the Chinese Academy of Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongzhi Wang (+86 551 6589 5180, wanghz@hfcas.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: At the time of surgical resection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.