Esophageal Squamous Cell CancerNCT07769866
Retlirafusp Alfa Combined With Chemoradiotherapy in Unresectable ESCC
A study testing Induction chemo-immunotherapy, Concurrent chemoradiotherapy (cCRT) and maintenance immunotherapy in people with Esophageal Squamous Cell Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer
- What is being tested?
- Induction chemo-immunotherapy, Concurrent chemoradiotherapy (cCRT) and maintenance immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Jun 2030
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the written informed consent form and agree to participate in this study;
- Pathologically confirmed esophageal squamous cell carcinoma;
- Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition);
- Aged 18-75 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;
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- Adequate major organ function, meeting the following laboratory criteria:
- Complete blood count: Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Blood biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug, and must use effective contraception during the study period and for at least 3 months after the last dose; Male patients with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 3 months after the last dose.
Who cannot join
- Prior or concurrent treatment with any of the following:
- Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy;
- Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose > 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses > 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease;
- Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug;
- Major surgery or severe trauma within 4 weeks prior to the first dose of study drug;
- Tumor-related exclusion criteria:
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- Non-esophageal cancer patients;
- Patients without unresectable locally advanced or metastatic esophageal cancer;
- Diagnosis of another malignancy within 5 years prior to the first dose of study drug, with the exception of cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
- Other criteria:
- Poorly controlled cardiac symptoms or diseases, including: a) New York Heart Association (NYHA) class ≥ 2 heart failure; b) Unstable angina; c) Myocardial infarction within 1 year; d) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
- Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring bronchodilators for medical intervention is excluded;
- Pregnant or breastfeeding women;
- History of severe allergic reactions to monoclonal antibodies, platinum agents, paclitaxel, or human serum albumin;
- Human immunodeficiency virus (HIV)-positive patients, or patients with active hepatitis (hepatitis B reference: hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥ 2000 IU/mL or ≥ 10⁴ copies/mL; hepatitis C reference: hepatitis C virus (HCV) antibody positive), or active pulmonary tuberculosis;
- Any other condition that, in the investigator's judgment, may necessitate premature termination from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Xiumei Ma, Doctor, 86-021-68383624, sallyma1203@163.com
sallyma1201@163.com
About this study
Official title: Retlirafusp Alfa Combined With Definitive Concurrent Chemoradiotherapy in Local Advanced Unresectable Esophageal Squamous Cell Cancer
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.
- Conditions
- Esophageal Squamous Cell Cancer
- Being tested
- Induction chemo-immunotherapy, Concurrent chemoradiotherapy (cCRT), maintenance immunotherapy
- Keywords
- Esophageal Squamous Cell Cancer, PD-L1, TGF-β, Retlirafusp Alfa, SHR-1701, concurrent chemoradiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemo-immunotherapyDrug
Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy:
Retlirafusp alfa 1800mg Day1 + Albumin-bound paclitaxel 125mg/m² Day 1 and Day 8 + Cisplatin 25mg/m² Day 1-3 every 3 weeks (Q3w)
Concurrent chemoradiotherapy (cCRT)Radiation
Radiation: 1.8Gy/Fx, total dose (DT) 50.4Gy/28Fx; Chemotherapy: Albumin-bound paclitaxel 60-80mg/m² + Cisplatin 25mg/m² Day 1 every week (Qw)
maintenance immunotherapyDrug
Retlirafusp Alfa 1800 mg on Day 1, Q3W, as maintenance therapy until disease progression or unacceptable toxicity, for up to 1 year; the total number of cycles for Retlirafusp Alfa induction and maintenance therapy should not exceed 15 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Retlirafusp Alfa Combined With Chemoradiotherapy | Experimental | Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year Receives: Drug: Induction chemo-immunotherapy; Radiation: Concurrent chemoradiotherapy (cCRT); Drug: maintenance immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year progression-free survival (PFS) rate
Progression-free survival (PFS) is defined as the time from the date of first study treatment administration to the first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)) or death from any cause, whichever occurs first.
The 1-year PFS rate is the proportion of participants who are alive and progression-free at 1 year (12 months) after the first dose.
Measured: From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769866
- Sponsor's protocol ID
- LY2026-128-A
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retlirafusp Alfa Combined With Definitive Concurrent Chemoradiotherapy in Local Advanced Unresectable Esophageal Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT07769866
- Acronym / sponsor ID
- LY2026-128-A
- Conditions
- Esophageal Squamous Cell Cancer
- Keywords
- Esophageal Squamous Cell Cancer, PD-L1, TGF-β, Retlirafusp Alfa, SHR-1701, concurrent chemoradiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 18 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.
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retlirafusp Alfa Combined With Chemoradiotherapy | Experimental | Drug: Induction chemo-immunotherapy, Radiation: Concurrent chemoradiotherapy (cCRT), Drug: maintenance immunotherapyParticipants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign the written informed consent form and agree to participate in this study;
- Pathologically confirmed esophageal squamous cell carcinoma;
- Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition);
- Aged 18-75 years, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
Key exclusion criteria (16 listed)
- Prior or concurrent treatment with any of the following:
- Tumor-related exclusion criteria:
- Other criteria:
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 |
|---|---|---|
| Induction chemo-immunotherapyParticipants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy: Retlirafusp alfa 1800mg Day1 + Albumin-bound paclitaxel 125mg/m² Day 1 and Day 8 + Cisplatin 25mg/m² Day 1-3 every 3 weeks (Q3w) | Drug | Retlirafusp Alfa Combined With Chemoradiotherapy |
| Concurrent chemoradiotherapy (cCRT)Radiation: 1.8Gy/Fx, total dose (DT) 50.4Gy/28Fx; Chemotherapy: Albumin-bound paclitaxel 60-80mg/m² + Cisplatin 25mg/m² Day 1 every week (Qw) | Radiation | Retlirafusp Alfa Combined With Chemoradiotherapy |
| maintenance immunotherapyRetlirafusp Alfa 1800 mg on Day 1, Q3W, as maintenance therapy until disease progression or unacceptable toxicity, for up to 1 year; the total number of cycles for Retlirafusp Alfa induction and maintenance therapy should not exceed 15 cycles. | Drug | Retlirafusp Alfa Combined With Chemoradiotherapy |
Primary outcome
1 year progression-free survival (PFS) rate
Time frame: From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months).
Progression-free survival (PFS) is defined as the time from the date of first study treatment administration to the first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)) or death from any cause, whichever occurs first. The 1-year PFS rate is the proportion of participants who are alive and progression-free at 1 year (12 months) after the first dose.
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction chemo-immunotherapy, Concurrent chemoradiotherapy (cCRT) and maintenance immunotherapy in people with Esophageal Squamous Cell Cancer, run by RenJi Hospital at 1 site 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 9 inclusion and 16 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: opening soon, as of the sponsor's last update on 18 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 1 site 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.
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 Xiumei Ma (86-021-68383624, sallyma1201@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year progression-free survival (PFS) rate (time frame: From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months).). 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 18 Aug 2026.