ClinicalTrials.gg
RecruitingNCT07796113Updated Aug 31, 2026

Adebrelimab With Famitinib and Chemotherapy as Neoadjuvant Therapy for ESCC

A Phase 2 interventional study of Adebrelimab + Famitinib + Chemotherapy in Esophageal Squamous Cell Carcinoma, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2025, registered Aug 2026).
  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma

Keywords

  • ESCC
  • Adebrelimab
  • Famitinib
  • Neoadjuvant
03

In context

Esophageal Squamous Cell Carcinoma

675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.

This study's planned enrollment of 24 is below the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed written and voluntarily agrees to participate in the study.
  2. or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
  3. 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).
  4. Expected to achieve R0 resection after therapy.
  5. Age between 18 and 75 years, male or female.
  6. ** performance status of 0-1.
  7. No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
  8. Planned to undergo surgical resection after completion of neoadjuvant therapy.
  9. No to surgery.
  10. Adequate organ function, defined as follows:

    a) Hematology (without the use of any blood components, hematopoietic growth factors, leukocyte or stimulants, or anemia-correcting agents within 14 days before first study drug administration):

    * (ANC) ≥ 1.5 × 10⁹/L

    * Platelet count ≥ 100 × 10⁹/L

    • ≥ 90 g/L b) Serum biochemistry:
    • Total ≤ 1.5 ×
    • ≤ 2.5 × ULN, AST ≤ 2.5 × ULN
    • Serum creatinine ≤ 1.5 × ULN, or ≥ 50 mL/min c) Coagulation:
    • ≤ 1.5 × ULN
    • APTT ≤ 1.5 × ULN
  11. Women of must have a negative serum pregnancy test within 72 hours prior to first dosing and must agree to use effective (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.
  12. Good compliance and willingness to adhere to study visits and follow-up requirements.

Exclusion criteria

Exclusion Criteria:

  1. Tumor invasion into adjacent vital structures of the esophageal lesion (e.g., major arteries or trachea).
  2. Presence of supraclavicular lymph node .
  3. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  4. Poor nutritional status with \< 18.5 kg/m²; patients may be reconsidered for inclusion after nutritional support and investigator assessment.
  5. Known to monoclonal antibodies, adebrelimab, paclitaxel, cisplatin, or other platinum-containing agents.
  6. Prior or current receipt of any of the following treatments:

    1. Any prior radiotherapy, chemotherapy, or other anti-tumor therapy for esophageal cancer;
    2. Use of drugs or systemic 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 disease;
    3. Receipt of a within 4 weeks before the first dose of study drug;
    4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
  7. 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.
  8. History of immunodeficiency, including positivity, other acquired or congenital immunodeficiency disorders, organ transplantation, or bone marrow transplantation.
  9. Uncontrolled or cardiac conditions, including but not limited to:

(1) Heart failure ≥ 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 ( 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 (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL) or active infection (HCV antibody positive and HCV RNA above the lower limit of detection).

14. History of another 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.

Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Adebrelimab + Famitinib + Chemotherapy

    Preoperative (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).

    Drug: Adebrelimab + Famitinib + Chemotherapy

Interventions

  • DrugAdebrelimab + Famitinib + Chemotherapy

    Drug pages: Adebrelimab · Famitinib

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 7 days after surgery

Secondary outcomes

  1. Major pathologic response (MPR)

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

    Time frame: 7 days after surgery

  2. R0 resection rate

    Proportion of R0 level surgery performed.

    Time frame: 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.

    Time frame: up to 2 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 months after the start.

Of 153 non-industry phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's planned 36 months is below that.

Counting every sponsor, half of 173 studies reached it within 40 months; a quarter within 28 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Aug 31, 2026
StartActual
Oct 30, 2025
Primary completionEst.
Oct 30, 2028
CompletionEst.
Oct 30, 2028
Last update
Aug 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07796113
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Oct 30, 2025
Primary completion
Oct 30, 2028 (estimated)
Completion
Oct 30, 2028 (estimated)
Last update
Aug 31, 2026

Study contacts

Yong Zhang, Dr
Contact
thouderous@163.com
17795600105

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Adebrelimab · Famitinib

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