Adebrelimab With Famitinib and Chemotherapy as Neoadjuvant Therapy for ESCC

NCT07796113 | Recruiting Phase 2

• 1 other identifier: XJTU1AF2025LSYY-819
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

ESCC; Adebrelimab; Famitinib; Neoadjuvant

Outcome Measures

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.

  7 days after surgery

Secondary Outcomes (3)

• Major pathologic response (MPR)

  7 days after surgery

• R0 resection rate

  postoperative 6 hours

• Event-free survival (EFS)

  up to 2 years

Study Arms (1)

Adebrelimab + Famitinib + Chemotherapy

EXPERIMENTAL

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

Adebrelimab + Famitinib + Chemotherapy DRUG

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.

Adebrelimab + Famitinib + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:
• a) 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

You may not qualify if:

• 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.
• Known hypersensitivity to monoclonal antibodies, adebrelimab, paclitaxel, cisplatin, or other platinum-containing agents.
• Prior or current receipt of any of the following treatments:
• 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:
• (1) 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.
• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shannxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

famitinib; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yong Zhang, Dr

CONTACT

17795600105; thouderous@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

CN (1)