Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07086469 | Recruiting Phase 2

• 1 other identifier: GASTO-10132
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.

Conditions

Toripalimab; Surufatinib; Neoadjuvant Immunochemotherapy; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma

Keywords

Toripalimab; Surufatinib; Neoadjuvant Immunochemotherapy; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival rate

  The 2-year progression-free survival rate refers to the proportion of patients who remain alive without evidence of disease progression at 24 months after initiation of treatment.

  2 years

Secondary Outcomes (7)

• Median overall survival (OS)

  2 years

• Objective Response Rate (ORR)

  2 months after CCRT

• Locoregional Progression-Free Survival (LRPFS)

  2 years

• Distant Metastasis-Free Survival (DMFS)

  2 years

• Treatment-related adverse events

  1 year after treatment

Study Arms (1)

The study group

EXPERIMENTAL

Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.

Drug: Neoadjuvant immunochemotherapy; Drug: Surufatinib Administration; Drug: Concurrent Chemotherapy; Radiation: Radiotherapy

Interventions

Neoadjuvant immunochemotherapy DRUG

Albumin-bound paclitaxel 260 mg/m² on day 1, cisplatin 25 mg/m² on days 1-3, and toripalimab 240 mg on day 1 of each 3-week cycle (q3w), for a total of 2 cycles.

The study group

Surufatinib Administration DRUG

Surufatinib 200 mg orally once daily (po, qd) on days 1-14, administered concurrently with immunochemotherapy. During radiotherapy, surufatinib will be administered at the start of each radiotherapy phase.

The study group

Concurrent Chemotherapy DRUG

Toripalimab 240 mg on day 1 of each 3-week cycle (q3w), starting one day prior to the initiation of radiotherapy. Weekly administration of albumin-bound paclitaxel 50 mg/m² and cisplatin 25 mg/m² on day 1 during the radiotherapy course.

The study group

Radiotherapy RADIATION

All patients will undergo thoracic intensity-modulated radiotherapy (IMRT), delivered once daily, 5 days per week, at a total prescribed dose of 50 Gy.

The study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
• Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower neck and chest, whole-body bone scintigraphy, or PET/CT; staged as T2-4, N0-3, M0-1 (M1 limited to supraclavicular lymph node metastasis).
• Male or female patients aged 18 to 80 years.
• No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.
• Expected life expectancy of at least 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
• Signed and dated informed consent form must be obtained prior to any study-related procedures.

You may not qualify if:

• Participation in another clinical trial simultaneously, except for observational (non-interventional) studies.
• Prior use of any targeted therapy.
• Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).
• Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, bowel obstruction, active bleeding disorders, or psychiatric/social conditions that may impair compliance with study requirements or the ability to provide informed consent.
• Performance status (PS) score of 2-4.
• Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \< 1000 mL; Absolute neutrophil count (ANC) \< 1.5 × 10⁹/L; Platelet count \< 100 × 10⁹/L; Hemoglobin \< 90 g/L; Creatinine clearance \< 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin \> 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 × ULN.
• Any condition that may interfere with the assessment of efficacy or safety of surufatinib.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

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

Study Officials

• Hui Liu

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Qiu

CONTACT

+862087343031; qiubo@sysucc.org.cn

Hui Liu

CONTACT

02087343031; liuhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 25, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 19, 2029
• Study Completion (Estimated): July 19, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)