Efficacy and Safety of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in BR-ESCC Patients

NCT04548440 | Completed Phase 2 DMC

• 1 other identifier: BRESCC-Preoperative 02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• R0 resection rate of patients who underwent surgery following preoperative treatment

  The proportion of people with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.

  up to 28 weeks

Secondary Outcomes (6)

• Pathological complete response rate of patients who received surgery following preoperative treatment

  up to 28 weeks

• Progression free survival from the date of first drug administration until the date of first documented progression or date of death, whichever came first.

  up to 28 weeks

• Tumor regression rate of patients following preoperative treatment

  immediately before surgery

• Relapse rate of patients who received surgery following preoperative treatment

  up to 28 weeks

• Overall survival from the date of first drug administration until the date of death from any cause

  up to 28 weeks

Study Arms (1)

Preoperative Sintilimab plus Nab-paclitaxel and Cisplatin

EXPERIMENTAL

Patients receive the following regimen every 3 weeks: Sintilimab 200mg IV on Day 1; Albumin-bound paclitaxel 125 mg/m2 IV on Day 1 and Day 8; Cisplatin 75mg/m2 IV on Day 1; Standard hydration regimen on Day 0-3 After 2-4 cycles, radiological evaluation and multidisciplinary assessment will be performed. If radical resection is possible, surgery is to be performed 3-6 weeks after the last chemotherapy session. In the case of a R0 resection, the investigator will decide whether to perform adjuvant therapy depending on the patient's condition; in the case of R1 or R2 resection, concurrent chemoradiotherapy is recommended. If the multidisciplinary assessment considers that radical resection is not possible, radical concurrent chemoradiotherapy is performed.

Drug: Sintilimab; Drug: Nab paclitaxel; Drug: Cisplatin

Interventions

Sintilimab DRUG

Route of administration: Intravenous

Also known as: Anti-PDCD1 monoclonal antibody IBI308, Tyvyt

Preoperative Sintilimab plus Nab-paclitaxel and Cisplatin

Nab paclitaxel DRUG

Route of administration: Intravenously over 30min

Also known as: Nanoparticle Albumin-Bound Paclitaxel, Abraxane

Preoperative Sintilimab plus Nab-paclitaxel and Cisplatin

Cisplatin DRUG

Route of administration: Intravenous

Also known as: CDDP, Platinol

Preoperative Sintilimab plus Nab-paclitaxel and Cisplatin

Eligibility Criteria

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

You may qualify if:

• Patients must provide a signed Informed Consent Form
• Age ≥18 years old
• Histological confirmation of T4N0-3M0 thoracic esophageal squamous cell carcinoma, absence of distant metastasis and confirmation of a borderline resectable lesion after multidisciplinary assessment using enhanced CT and/or Endoscopic Esophageal Ultrasound or Endobronchial Ultrasound. The definition of a borderline resectable lesion includes: CT showing that the fat gap between the tumor and the aorta is blurred, the angle between three contiguous planes (2mm/layer) and the aorta exceeds 90 degrees; or Endoscopic Esophageal Ultrasound revealing that the tumor has invaded the adventitia layer of the esophagus, and the boundary with the aorta is unclear; or Endobronchial Ultrasound showing an unclear border between the tumor and trachea or bronchus, but has yet invaded the trachea or bronchial mucosa or submucosa
• Patients have not received any anti-tumor treatment for esophageal cancer (including surgery, chemotherapy, interventional therapy, immunotherapy, radiotherapy, etc.)
• Life expectancy ≥3 months
• General physical status (ECOG PS score) 0-1 points
• Blood routine test (within 7 days): Hb ≥9g/L, NE ≥1.5×109/L, PLT ≥90×109/L
• Liver and kidney function test (within 7 days): total bilirubin ≤1.5 UNL, creatinine ≤1.5× UNL, AST /ALT ≤2.5xUNL, ALP ≤5.0xUNL
• No serious complications such as active gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, fever unrelated to malignant disease\>38℃
• Patients with reproductive potential should take effective contraceptive measures
• Patients with good compliance and that can attend scheduled follow up to assess the efficacy and adverse reactions of the treatment

You may not qualify if:

• Patients with cervical esophageal squamous cell carcinoma
• Patients with distant metastases
• Patients with a high risk of complete esophageal obstruction and require interventional therapy
• Patients with stent implantation in the esophagus or trachea
• Patients with an esophageal tumor that invaded adjacent organs (aorta or trachea), causing an increased risk of bleeding or perforation, or patients with a fistula
• Concurrent primary cancers (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
• History of immunosuppressive drug use within 1 week before treatment, excluding nasal spray, inhalation or use of local glucocorticoids or physiological doses of systemic glucocorticoids (not exceeding 10 mg/day prednisone or equivalent doses of other glucocorticoids) or glucocorticoids used to prevent contrast agent allergy.
• Patients with active or a past history (within 2 years) of autoimmune disease that need symptomatic treatment (Patient diagnosed with vitiligo, psoriasis, alopecia, or Grave disease that did not require systemic treatment within the past 2 years, hypothyroidism that requires only thyroid hormone replacement therapy and type I diabetes patients treated with insulin replacement therapy only are eligible)
• Patients with a history of primary immunodeficiency disease
• Patients with a history of active tuberculosis
• Patients with a past history of allogenic organ transplantation and allogeneic hematopoietic stem cell transplantation
• Patients diagnosed with interstitial lung disease that require steroid therapy
• Patients with a known history of allergy to any monoclonal antibody or chemotherapeutic drugs (taxanes, cisplatin) or their constituents.
• Patients with a history of severe heart disease, including: history of congestive heart failure, patients with high-risk of uncontrolled arrhythmias, angina pectoris requiring medical treatment, clinically diagnosed heart valve disease, history of severe myocardial infarction and refractory hypertension
• Patients with chronic diarrhea (4 or more watery stools per day) and patient with renal insufficiency

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator
• CSPC Pharmaceutical Group Limited: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab; Taxes; Albumin-Bound Paclitaxel; Cisplatin

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)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yuhong Li, MD, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: September 9, 2020
• First Posted: September 14, 2020
• Study Start: August 31, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: When the study complete, the data will become available for 3 years.
• Access Criteria: With the permission of professor Yuhong Li

Locations

CN (1)