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Esophageal CancerPhase 2NCT07770672

An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)/¹⁸F-FDG (2-Deoxy-2-[¹⁸F]Fluoro-D-glucose) Dual Imaging

A Phase 2 study testing Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus Chemotherapy in people with Esophageal Cancer and ESCC, run by Tan Lijie at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evaluate whether two positron emission tomography/computed tomography (PET/CT) scans performed before treatment-68Ga-FAPI and 18F-FDG-can help predict how well patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma respond to immunotherapy plus chemotherapy given before… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer, ESCC
What is being tested?
Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteChina
Study dates
20 Aug 2026to 1 Mar 2029
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

  • Participants must meet all of the following criteria to be eligible for enrollment:
  • Voluntarily agree to participate in the study and provide written informed consent.
  • Histologically or cytologically confirmed esophageal squamous cell carcinoma.
  • Thoracic esophageal cancer assessed by computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography/computed tomography (PET/CT), or other appropriate imaging, with clinical stage II to IVA disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
  • Considered by a surgeon to be suitable for an R0 resection and planned to undergo surgery after completing neoadjuvant treatment.
  • Undergo both 18F-FDG and 68Ga-FAPI PET/CT imaging at baseline. For Stage 2, the participant's 18F-FDG and 68Ga-FAPI PET/CT parameters must meet the criteria of the prediction model for lack of pathologic complete response (non-pCR).
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  • Aged 18 to 75 years, inclusive, with no restriction based on sex.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  • No previous antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, or other antitumor treatment.
  • No contraindication to surgery.
  • Adequate major organ function, as defined by all of the following:
  • Hematologic function. No blood components, hematopoietic growth factors, leukocyte-elevating agents, platelet-elevating agents, or medications used to correct anemia are permitted within 14 days before the first administration of study treatment:
  • Absolute neutrophil count ≥1.5 × 10^9/L;
  • Platelet count ≥100 × 10^9/L;
  • Hemoglobin ≥90 g/L.
  • Biochemical function:
  • Total bilirubin ≤1.5 × the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) ≤2.5 × ULN and aspartate aminotransferase (AST) ≤2.5 × ULN;
  • Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula.
  • Coagulation function:
  • International normalized ratio (INR) ≤1.5 × ULN;
  • Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.
  • Pulmonary function:
  • Forced expiratory volume in 1 second (FEV1) ≥1.2 L;
  • FEV1 percentage of predicted value (FEV1%) ≥50%;
  • Diffusing capacity of the lung for carbon monoxide (DLCO) ≥50%.
  • A female participant of childbearing potential must have a negative serum pregnancy test within 72 hours before the first administration of study treatment, must not be breastfeeding, and must agree to use a highly effective method of contraception with an annual failure rate of less than 1%, such as an intrauterine device, oral contraceptive, or condom, throughout the study and until 2 months after the last dose of adebrelimab or 6 months after the last dose of chemotherapy, whichever is longer. A male participant with a female partner of childbearing potential must be surgically sterile or agree to use an effective method of contraception throughout the study and until 2 months after the last dose of adebrelimab or 3 months after the last dose of chemotherapy, whichever is longer. Sperm donation is not permitted during the study.
  • Able and willing to comply with the study procedures and follow-up requirements.

Who cannot join

  • Participants meeting any of the following criteria will be excluded:
  • Obvious invasion by the tumor or involved lymph nodes into organs adjacent to the esophageal lesion, including the pleura, pericardium, azygos vein, diaphragm, peritoneum, major arteries, vertebral body, or trachea.
  • Supraclavicular lymph node metastasis.
  • Diagnosis of another malignant tumor within 5 years before the first administration of study treatment, except for a malignancy with a low risk of metastasis or death and an expected 5-year survival rate greater than 90%. Participants with adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or a similar malignancy may be considered eligible.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Poor nutritional status, defined as a body mass index (BMI) of less than 18.5 kg/m2. A participant whose nutritional status is corrected through appropriate nutritional support before the initiation of treatment may still be considered eligible following assessment by the principal investigator.
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  • History of an allergic reaction to a monoclonal antibody.
  • Receipt of any tumor-directed radiotherapy, chemotherapy, or other antitumor medication.
  • Use of immunosuppressive medication or systemic corticosteroid treatment for an immunosuppressive purpose within 2 weeks before the first administration of study treatment at a dose greater than 10 mg/day of prednisone or an equivalent dose. In the absence of an active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement at a dose greater than 10 mg/day of prednisone or an equivalent dose are permitted.
  • Receipt of a live attenuated vaccine within 4 weeks before the first administration of study treatment.
  • Major surgery or severe trauma within 4 weeks before the first administration of study treatment.
  • Any active autoimmune disease or history of an autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. Participants with hypothyroidism may be considered eligible after hormone replacement therapy. Participants with psoriasis or childhood asthma or allergy that has completely resolved and requires no intervention during adulthood may be considered eligible; however, participants requiring medical intervention with a bronchodilator are not eligible.
  • History of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, another acquired or congenital immunodeficiency disorder, a history of organ transplantation, or a history of allogeneic bone marrow transplantation.
  • Poorly controlled cardiac symptoms or disease, including but not limited to:
  • New York Heart Association (NYHA) class II or higher heart failure;
  • Unstable angina;
  • Myocardial infarction within the previous year;
  • Clinically significant supraventricular or ventricular arrhythmia that has not received appropriate clinical intervention or remains poorly controlled after clinical intervention.
  • A serious infection of greater than Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) within 4 weeks before the first administration of study treatment, including severe pneumonia requiring hospitalization, bacteremia, or other serious infectious complications; evidence of active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection within 14 days before the first administration of study treatment; or a requirement for oral or intravenous antibiotic treatment within that period. Prophylactic antibiotic use is permitted.
  • Active tuberculosis identified through medical history or CT examination; a history of active tuberculosis within 1 year before enrollment; or a history of active tuberculosis more than 1 year before enrollment without having received appropriate standard treatment.
  • Active hepatitis B, defined as hepatitis B virus DNA ≥2,000 IU/mL or ≥10^4 copies/mL; or hepatitis C, defined as a positive hepatitis C virus antibody test together with hepatitis C virus RNA above the lower limit of detection of the assay.
  • Pregnant or breastfeeding female participants.
  • Any other factor that, in the investigator's judgment, may result in forced premature discontinuation from the study, including another serious illness requiring concomitant treatment, including a psychiatric disorder; alcohol abuse; drug abuse; or family or social circumstances that may affect the participant's 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.

Han Tang contact

021-64041990

tang.han@zs-hospital.sh.cn

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai

    Han Tang, 021-64041990, tang.han@zs-hospital.sh.cn

Other trials in China

About this study

This study will evaluate whether two positron emission tomography/computed tomography (PET/CT) scans performed before treatment-68Ga-FAPI and 18F-FDG-can help predict how well patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma respond to immunotherapy plus chemotherapy given before surgery. The study hypothesis is that information from the two scans can identify patients who are unlikely to have a pathologic complete response (pCR), meaning no remaining cancer in the removed esophagus or lymph nodes, and that retlirafusp alfa may improve pathologic response compared with adebrelimab when each is combined with chemotherapy in these patients.

This study has two stages and plans to enroll 92 adults aged 18 to 75 years with previously untreated, stage II to IVA, resectable thoracic esophageal squamous cell carcinoma. All participants will undergo both PET/CT scans before treatment.

Being tested
Retlirafusp Alfa Plus Chemotherapy, Adebrelimab Plus Chemotherapy
Keywords
PET-CT, ESCC, Neoadjuvant therapy, Adebrelimab (SHR-1316), Retlirafusp alfa (SHR-1701)
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retlirafusp Alfa Plus ChemotherapyDrug

    participants predicted by the 68Ga-FAPI/18F-FDG dual-imaging model to be unlikely to achieve a pathologic complete response will be randomly assigned to receive retlirafusp alfa in combination with nab-paclitaxel and cisplatin of each 3-week cycle for 2 cycles. Participants without a contraindication to surgery will undergo esophagectomy 4 to 6 weeks after the last treatment dose.

  • Adebrelimab Plus ChemotherapyDrug

    participants predicted by the 68Ga-FAPI/18F-FDG dual-imaging model to be unlikely to achieve a pathologic complete response will be randomly assigned to receive Adebrelimab in combination with nab-paclitaxel and cisplatin of each 3-week cycle for 2 cycles. Participants without a contraindication to surgery will undergo esophagectomy 4 to 6 weeks after the last treatment dose.

Study groups in NCT07770672
Study groupRoleWhat they receive
Retlirafusp Alfa Plus ChemotherapyExperimentalNot described
Receives: Drug: Retlirafusp Alfa Plus Chemotherapy
Adebrelimab Plus ChemotherapyActive comparatorNot described
Receives: Drug: Adebrelimab Plus Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pCR

    Complete Pathological response, no residual viable tumor cells in the primary tumor or lymph nodes.

    Measured: One week after surgery

Secondary outcomes (5)

  1. MPR

    Major Pathological Response, the residual tumor cells in the primary tumor were less than 10%.

    Measured: One week after surgery

  2. R0 resection rate

    Both ends and circumferential margins were negative

    Measured: One week after surgery

  3. EFS

    Event-free survival (EFS) was assessed by the investigator per RECIST 1.1 and was defined as the time from randomization to the occurrence of a study-defined event.

    Measured: 3 years after treatment initiation

  4. OS

    Overall survival (OS) was defined as the time from randomization to death from any cause.

    Measured: 3 years after treatment initiation

  5. safty

    incidence of adverse events and surgical complications during treatment

    Measured: Within 90 days after treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion1 Mar 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770672
Sponsor's protocol ID
B2026-431R
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Retlirafusp Alfa Plus Chemotherapy and Adebrelimab Plus Chemotherapy in people with Esophageal Cancer and ESCC, run by Tan Lijie 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 28 inclusion and 23 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.

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 Han Tang (021-64041990, tang.han@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: One week after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07770672.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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