Adebrelimab With Famitinib and Chemotherapy as Neoadjuvant Therapy for ESCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Adebrelimab + Famitinib + ChemotherapyExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.