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Esophageal Squamous Cell CarcinomaPhase 2NCT07796113

Adebrelimab With Famitinib and Chemotherapy as Neoadjuvant Therapy for ESCC

A Phase 2 study testing Adebrelimab + Famitinib + Chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, single-arm, exploratory clinical study enrolling patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma (ESCC) confirmed by histology or cytology. 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?
Adebrelimab + Famitinib + Chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
30 Oct 2025to 30 Oct 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

  • Signed written informed consent and voluntarily agrees to participate in the study.
  • Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
  • Thoracic esophageal cancer evaluated by CT, MRI, or EUS, with clinical stage T1b-T2N+ or T3-T4a, any N (according to the AJCC 8th edition).
  • Expected to achieve R0 resection after neoadjuvant therapy.
  • Age between 18 and 75 years, male or female.
  • **ECOG performance status of 0-1.
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  • No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
  • Planned to undergo surgical resection after completion of neoadjuvant therapy.
  • No contraindications to surgery.
  • Adequate organ function, defined as follows:
  • Hematology (without the use of any blood components, hematopoietic growth factors, leukocyte or platelet stimulants, or anemia-correcting agents within 14 days before first study drug administration):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
  • Platelet count ≥ 100 × 10⁹/L
  • Hemoglobin ≥ 90 g/L b) Serum biochemistry:
  • Total bilirubin ≤ 1.5 × ULN
  • ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min c) Coagulation:
  • INR ≤ 1.5 × ULN
  • APTT ≤ 1.5 × ULN
  • Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to first dosing and must agree to use effective contraception (such as intrauterine device, oral contraceptives, or condoms) during the study and for at least 3 months after the last dose.Male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose.
  • Good compliance and willingness to adhere to study visits and follow-up requirements.

Who cannot join

  • Tumor invasion into adjacent vital structures of the esophageal lesion (e.g., major arteries or trachea).
  • Presence of supraclavicular lymph node metastasis.
  • Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Poor nutritional status with BMI < 18.5 kg/m²; patients may be reconsidered for inclusion after nutritional support and investigator assessment.
  • Known hypersensitivity to monoclonal antibodies, adebrelimab, paclitaxel, cisplatin, or other platinum-containing agents.
  • Prior or current receipt of any of the following treatments:
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  • Any prior radiotherapy, chemotherapy, or other anti-tumor therapy for esophageal cancer;
  • Use of immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes (prednisone >10 mg/day or equivalent) within 2 weeks before the first dose of study drug. Inhaled or topical corticosteroids, or physiologic replacement doses (>10 mg/day prednisone or equivalent) are permitted in the absence of active autoimmune disease;
  • Receipt of a live attenuated vaccine within 4 weeks before the first dose of study drug;
  • Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
  • Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients with thyroid disorders controlled on hormone replacement may be eligible). Patients with psoriasis or childhood asthma/allergies that have resolved without intervention may be eligible, but those requiring bronchodilators are excluded.
  • History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency disorders, organ transplantation, or allogeneic bone marrow transplantation.
  • Uncontrolled or clinically significant cardiac conditions, including but not limited to:
  • Heart failure ≥ NYHA Class II; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias that are uncontrolled despite treatment.
  • 10. Severe infection (CTCAE grade >2) within 4 weeks prior to first dosing, such as pneumonia requiring hospitalization, bacteremia, or other severe infections.
  • Patients with active pulmonary infection on baseline imaging, symptoms or signs of infection, or those requiring oral or intravenous antibiotics within 14 days prior to first dosing are excluded, except for prophylactic antibiotic use.
  • 11. Active tuberculosis (TB) infection confirmed by history or CT findings, history of active TB within 1 year before enrollment, or history of TB more than 1 year prior without adequate treatment.
  • 12. Tumor encasement of major blood vessels or presence of significant necrosis or cavitation on imaging that, in the investigator's judgment, would increase the risk of bleeding.
  • 13. Active hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL) or active hepatitis C infection (HCV antibody positive and HCV RNA above the lower limit of detection).
  • 14. History of another malignancy within 5 years prior to the first dose, except for malignancies with negligible risk of metastasis or death (e.g., adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).
  • 15. Pregnant or breastfeeding women. 16. Any other condition that, in the investigator's judgment, may interfere with study participation or result in early withdrawal, including severe concomitant diseases (including psychiatric disorders) requiring treatment, alcohol or drug abuse, or social/familial factors that may affect compliance or safety.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yong Zhang, Dr contact

17795600105

thouderous@163.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shannxi, 710000

    Yong Zhang, Dr, 17795600105, thouderous@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm Exploratory Study of Adebrelimab Combined With Famitinib and Chemotherapy as Neoadjuvant Treatment for Thoracic Esophageal Squamous Cell Carcinoma

This is a prospective, single-arm, exploratory clinical study enrolling patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma (ESCC) confirmed by histology or cytology. The study aims to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab in combination with famitinib and chemotherapy in this population. The primary endpoint is the pathological complete response (pCR) rate, with a planned enrollment of 24 patients.

Being tested
Adebrelimab + Famitinib + Chemotherapy
Keywords
ESCC, Adebrelimab, Famitinib, 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.

  • Adebrelimab + Famitinib + ChemotherapyDrug

    Adebrelimab 1200 mg will be administered intravenously on Day 1 of each 3-week cycle (Q3W).

    Paclitaxel 175 mg/m² and cisplatin 75 mg/m² will also be administered intravenously on Day 1 (Q3W).

    Drugs will be infused in the following order with at least a 30-minute interval: Adebrelimab → Paclitaxel → Cisplatin.

    Famitinib 10 mg will be taken orally once daily (po, qd), 30 minutes after a meal, for 2 weeks on treatment followed by 1 week off (Q3W).

    A total of 2 treatment cycles will be administered before surgery.

Study groups in NCT07796113
Study groupRoleWhat they receive
Adebrelimab + Famitinib + ChemotherapyExperimentalPreoperative (Neoadjuvant) Treatment: Each treatment cycle lasts 3 weeks (Q3W), for a total of 2 cycles. Adebrelimab 1200 mg, intravenous infusion on Day 1, Q3W Paclitaxel 175 mg/m², intravenous infusion on Day 1, Q3W Cisplatin 75 mg/m², intravenous infusion on Day 1, Q3W Drugs are administered in the following order with at least a 30-minute interval between infusions: Adebrelimab → Paclitaxel → Cisplatin. Famitinib 10 mg orally once daily (po, qd), administered 30 minutes after a meal, for 2 weeks on followed by 1 week off (Q3W).
Receives: Drug: Adebrelimab + Famitinib + Chemotherapy

What is being measured

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

  1. Pathological complete response rate(pCR)

    The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.

    Measured: 7 days after surgery

Secondary outcomes (3)

  1. Major pathologic response (MPR)

    MPR is defined as less than 10% residual viable tumor after neoadjuvant therapy.

    Measured: 7 days after surgery

  2. R0 resection rate

    Proportion of R0 level surgery performed.

    Measured: postoperative 6 hours

  3. Event-free survival (EFS)

    The length of time after completion of primary cancer treatment during which the patient remains free from certain complications or events that the treatment was intended to prevent or delay.

    Measured: up to 2 years

Timeline

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

  1. First posted31 Aug 2026
  2. Study start30 Oct 2025
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion30 Oct 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796113
Sponsor's protocol ID
XJTU1AF2025LSYY-819
Status last verified
Aug 2026
First submitted
26 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab + Famitinib + Chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University 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 21 inclusion and 21 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 31 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 Yong Zhang, Dr (17795600105, thouderous@163.com), 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: 7 days 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 NCT07796113.

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 31 Aug 2026.

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