Esophageal Squamous Cell CarcinomaPhase 2NCT07618910
Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC
A Phase 2 study testing Retlirafusp alfa, Nab paclitaxel and Cisplatin for injection in people with Esophageal Squamous Cell Carcinoma, run by Tang-Du Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Retlirafusp alfa, Nab paclitaxel and Cisplatin for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed and dated written informed consent to participate in this study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
- Clinically staged as thoracic ESCC evaluated by CT, MRI, or endoscopic ultrasonography (EUS), with a clinical stage of T1b-4aN+M0 or T2-4N0M0 according to the American Joint Committee on Cancer (AJCC) 8th edition. For T2N0 patients, at least one high-risk factor must be present: lymphovascular invasion (LVI), tumor size >= 3 cm, or poor differentiation.
- Anticipated to achieve an R0 resection.
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent, of either sex.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
- Planned to undergo definitive surgical resection following the completion of neoadjuvant therapy.
- No contraindications to surgical resection.
- Adequate major organ functions, meeting the following laboratory criteria: 10a) Hematology (no blood components, cell growth factors, leukogenic agents, platelet-stimulating agents, or anemia-correcting therapies allowed within 14 days prior to the first dose of study drug): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Hemoglobin >= 90 g/L. 10b) Blood Biochemistry: Total bilirubin (TBIL) <= 1.5 x Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) <= 2.5 x ULN; Aspartate aminotransferase (AST) <= 2.5 x ULN; Serum creatinine <= 1.5 x ULN, or creatinine clearance (CrCl) >= 50 mL/min. 10c) Coagulation Function: International Normalized Ratio (INR) <= 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) <= 1.5 x ULN.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug and agree to use highly effective methods of contraception (e.g., intrauterine device [IUD], contraceptives, or condoms) during the trial and for at least 3 months after the last dose. Male subjects whose partners are females of childbearing potential must be surgically sterile or agree to use highly effective contraception during the trial and for at least 3 months after the last dose.
- Good compliance and willingness to cooperate with the scheduled follow-up visits.
Who cannot join
- Tumors with clear invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea).
- Presence of supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage.
- Poor nutritional status with Body Mass Index (BMI) < 18.5 kg/m2; however, patients whose nutritional status is corrected after symptomatic nutritional support before enrollment may still be considered after evaluation by the principal investigator.
- Known history of hypersensitivity to the study drugs.
- Prior or current receipt of any of the following treatments: 6a) Any prior anti-tumor radiotherapy, chemotherapy, or other anti-tumor medications. 6b) Use of immunosuppressive medications or systemic corticosteroid therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or equivalent dose) within 2 weeks prior to the first dose of study drug. 6c) Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug. 6d) Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
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- Active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial lung disease, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (subjects stable on hormone replacement therapy can be considered for inclusion). Subjects with psoriasis or childhood asthma/allergies that have completely resolved without any adult intervention may be considered for inclusion; however, patients requiring medical intervention with bronchodilators are excluded.
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- Uncontrolled clinical cardiac symptoms or diseases, including but not limited to: (1) New York Heart Association (NYHA) Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that are uncontrolled or poorly controlled despite clinical intervention.
- Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging indicating active pulmonary inflammation, signs or symptoms of infection within 14 days prior to the first dose of study drug, or requiring oral or intravenous antibiotic therapy (except for prophylactic antibiotic use).
- Active tuberculosis infection detected by medical history or CT scan, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without formal standard treatment.
- Screening imaging showing tumor encasement of major blood vessels or significant necrosis/cavitation, where the investigator judges that study participation would pose a high risk of hemorrhage.
- Active hepatitis B (HBV DNA >= 2000 IU/mL or 10^4 copies/mL), or hepatitis C (HCV antibody positive and HCV RNA above the lower limit of detection of the assay).
- Diagnosis of other malignant tumors within 5 years prior to the first dose of study drug, unless the malignancy carries a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.
- Pregnant or lactating females.
- Any other factors that, in the judgment of the investigator, may compel premature termination of study participation, such as other severe medical or psychiatric conditions requiring concomitant therapy, alcohol abuse, drug abuse, familial or social factors, or any other conditions that may compromise subject safety or compliance.
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
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shaanxi, 710032
Xiaolong Yan, Dr, 029-847171569, yanxiaolong@fmmu.edu.cn
About this study
Official title: A Prospective, Single-Arm, Exploratory Study of Retlirafusp Alfa Combined With Chemotherapy as Neoadjuvant Therapy for Thoracic Esophageal Squamous Cell Carcinoma
This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC).
The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.
Read the detailed description
The study comprises three sequential phases: a Screening Period, a Treatment Period, and a Follow-up Period.
Screening Period: Conducted within a maximum of 21 days from the signing of the Informed Consent Form (ICF) up to the first administration of the study drug.
Treatment Period: Includes both the neoadjuvant therapy phase and the subsequent surgical resection.
Follow-up Period: Consists of safety follow-up, tumor progression/recurrence follow-up, and overall survival follow-up.
Neoadjuvant Regimen and Administration Schedule:
Patients will receive 3 cycles of neoadjuvant therapy consisting of retlirafusp alfa combined with nab-paclitaxel and cisplatin. Surgical resection is scheduled to be performed 4 to 6 weeks following the completion of the neoadjuvant therapy.
A dosing window of ±3 days is permissible during the study treatment period. Prior to each administration (within 3 days before dosing), subjects must undergo standard safety evaluations, including physical examinations (as needed), laboratory tests, and Eastern Cooperative Oncology Group (ECOG) performance status assessments, to confirm treatment tolerance. Laboratory tests completed during the screening period within the protocol-specified timeframe do not need to be repeated prior to the first dose. Safety assessments will be continuously monitored throughout the study duration to ensure subject safety.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Retlirafusp alfa, Nab paclitaxel, Cisplatin for injection
- Keywords
- ESCC, Retlirafusp alfa, Neoadjuvant
- 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.
Retlirafusp alfaDrug
Administered at a fixed dose of 1800 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. Retlirafusp alfa must be infused first in the sequence, with an interval of at least 30 minutes before the subsequent administration of nab-paclitaxel.
Nab paclitaxelDrug
Administered at a dose of 130 mg/m² via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 3 cycles.
Cisplatin for injectionDrug
Administered at a dose of 75 mg/m² via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Retlirafusp Alfa plus Nab-Paclitaxel and Cisplatin | Experimental | Subjects will receive 3 cycles of neoadjuvant therapy. The regimen consists of Retlirafusp alfa combined with nab-paclitaxel and cisplatin. A dosing window of 3 days is allowed during the treatment period. Prior to each administration (within 3 days before dosing), standard safety evaluations, including physical examinations, laboratory tests, and ECOG performance status assessments, must be completed to confirm treatment tolerance. Following the completion of the 3-cycle neoadjuvant therapy, surgical resection will be performed after a rest period of 4 to 6 weeks. Safety, tumor progression/recurrence, and overall survival will be continuously monitored during the follow-up period. Receives: Drug: Retlirafusp alfa; Drug: Nab paclitaxel; Drug: Cisplatin for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Measured: Pathological detection after surgery within 1 month
Secondary outcomes (4)
Major pathological response rate (MPR)
Measured: Pathological detection after surgery within 1 month
Event-free survival (EFS)
Measured: from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 36 months)
Overall survival（OS）
Measured: from randomization to death from any cause，assessed up to 36 months
R0 Resection Rate
Measured: after surgery within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Tang-Du 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618910
- Sponsor's protocol ID
- IIT2026043
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Exploratory Study of Retlirafusp Alfa Combined With Chemotherapy as Neoadjuvant Therapy for Thoracic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07618910
- Acronym / sponsor ID
- IIT2026043
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- ESCC, Retlirafusp alfa, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 1 Jun 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 is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC).
The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.
Detailed description
The study comprises three sequential phases: a Screening Period, a Treatment Period, and a Follow-up Period.
Screening Period: Conducted within a maximum of 21 days from the signing of the Informed Consent Form (ICF) up to the first administration of the study drug.
Treatment Period: Includes both the neoadjuvant therapy phase and the subsequent surgical resection.
Follow-up Period: Consists of safety follow-up, tumor progression/recurrence follow-up, and overall survival follow-up.
Neoadjuvant Regimen and Administration Schedule:
Patients will receive 3 cycles of neoadjuvant therapy consisting of retlirafusp alfa combined with nab-paclitaxel and cisplatin. Surgical resection is scheduled to be performed 4 to 6 weeks following the completion of the neoadjuvant therapy.
A dosing window of ±3 days is permissible during the study treatment period. Prior to each administration (within 3 days before dosing), subjects must undergo standard safety evaluations, including physical examinations (as needed), laboratory tests, and Eastern Cooperative Oncology Group (ECOG) performance status assessments, to confirm treatment tolerance. Laboratory tests completed during the screening period within the protocol-specified timeframe do not need to be repeated prior to the first dose. Safety assessments will be continuously monitored throughout the study duration to ensure subject safety.
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 plus Nab-Paclitaxel and Cisplatin | Experimental | Drug: Retlirafusp alfa, Drug: Nab paclitaxel, Drug: Cisplatin for injectionSubjects will receive 3 cycles of neoadjuvant therapy. The regimen consists of Retlirafusp alfa combined with nab-paclitaxel and cisplatin. A dosing window of 3 days is allowed during the treatment period. Prior to each administration (within 3 days before dosing), standard safety evaluations, including physical examinations, laboratory tests, and ECOG performance status assessments, must be completed to confirm treatment tolerance. Following the completion of the 3-cycle neoadjuvant therapy, surgical resection will be performed after a rest period of 4 to 6 weeks. Safety, tumor progression/recurrence, and overall survival will be continuously monitored during the follow-up period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily signed and dated written informed consent to participate in this study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
- Clinically staged as thoracic ESCC evaluated by CT, MRI, or endoscopic ultrasonography (EUS), with a clinical stage of T1b-4aN+M0 or T2-4N0M0 according to the American Joint Committee on Cancer (AJCC) 8th edition. For T2N0 patients, at least one high-risk factor must be present: lymphovascular invasion (LVI), tumor size >= 3 cm, or poor differentiation.
- Anticipated to achieve an R0 resection.
- Age between 18 and 75 years (inclusive) at the time of signing the informed consent, of either sex.
Key exclusion criteria (16 listed)
- Tumors with clear invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea).
- Presence of supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage.
- Poor nutritional status with Body Mass Index (BMI) < 18.5 kg/m2; however, patients whose nutritional status is corrected after symptomatic nutritional support before enrollment may still be considered after evaluation by the principal investigator.
- Known history of hypersensitivity to the study drugs.
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 |
|---|---|---|
| Retlirafusp alfaAdministered at a fixed dose of 1800 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. Retlirafusp alfa must be infused first in the sequence, with an interval of at least 30 minutes before the subsequent administration of nab-paclitaxel. | Drug | Retlirafusp Alfa plus Nab-Paclitaxel and Cisplatin |
| Nab paclitaxelAdministered at a dose of 130 mg/m² via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 3 cycles. | Drug | Retlirafusp Alfa plus Nab-Paclitaxel and Cisplatin |
| Cisplatin for injectionAdministered at a dose of 75 mg/m² via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. | Drug | Retlirafusp Alfa plus Nab-Paclitaxel and Cisplatin |
Primary outcome
Pathological complete response rate (pCR)
Time frame: Pathological detection after surgery within 1 month
4 secondary outcomes
Major pathological response rate (MPR)
Time frame: Pathological detection after surgery within 1 month
Event-free survival (EFS)
Time frame: from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 36 months)
Overall survival（OS）
Time frame: from randomization to death from any cause，assessed up to 36 months
R0 Resection Rate
Time frame: after surgery within 1 month
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 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Retlirafusp alfa, Nab paclitaxel and Cisplatin for injection in people with Esophageal Squamous Cell Carcinoma, run by Tang-Du 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 12 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 1 Jun 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.
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 Xiaolong Yan, Dr (029-847171569, yanxiaolong@fmmu.edu.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 (pCR) (time frame: Pathological detection after surgery within 1 month). 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 1 Jun 2026.