A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma

NCT06152978 | Not Yet Recruiting Phase 2

• 1 other identifier: ECTOP-2006
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

perioperative; esophageal cancer; programmed cell death protein-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  EFS is defined as the time from R0 resection to disease recurrence or metastases or death for subjects achieving radical resection or the time from enrollment to disease progression or death for subjects not achieving radical resection.

  12 months

Secondary Outcomes (5)

• R0 surgery rate

  20 months

• pCR rate

  20 months

• Disease-free survival (DFS)

  24 months

• Overall Survival (OS)

  24 months

• adverse events

  24 months

Study Arms (2)

Sintilimab plus chemotherapy

EXPERIMENTAL

Sintilimab: 200mg; cisplatin: 75mg/m2, d1, routine hydration for 3 days; nab-paclitaxel: 260mg/m2, d1, every 3 weeks, 2-3 cycles.

Drug: Sintilimab; Drug: Chemotherapy

Chemotherapy

ACTIVE COMPARATOR

Cisplatin: 75mg/m2, d1, routine hydration for 3 days; nab-paclitaxel: 260mg/m2, d1, every 3 weeks, 2-3 cycles.

Drug: Chemotherapy

Interventions

Sintilimab DRUG

Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.

Sintilimab plus chemotherapy

Chemotherapy DRUG

Cisplatin (75mg/m2) wih routine hydration for 3 days and nab-paclitaxel (260mg/m2) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.

Chemotherapy; Sintilimab plus 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:

• Esophageal squamous cell carcinoma suggested by gastroscopic histopathology.
• The primary tumor is located in the middle and lower of the esophagus.
• cT2-4aN0～3M0 or cT1N+M0 diagnosed by enhanced CT/MRI scan.
• Tumor was evaluated as resectable by surgeon before neoadjuvant therapy.
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
• Can eat semi-liquid food.
• Less than 20% body weight loss within 6 months prior to enrollment.
• Sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol.
• With adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery.
• Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 180 days after the last dose of the test drug.
• Agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing.

You may not qualify if:

• With metastases or unresectable primary lesion suggested by imaging before treatment.
• History of previous subtotal gastrectomy.
• Patients with active malignancy within 2 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer.
• Received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy.
• With signs of pre-esophageal perforation. With any active autoimmune disease or has a history of autoimmune disease.

Sponsors & Collaborators

• Fudan University: lead
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Interventions

sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; 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

• Haiquan Chen, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haiquan Chen, MD

CONTACT

+86 13601973588; hqchen1@yahoo.com

Bin Li, MD

CONTACT

+86 18017317295; lb0256327@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: December 1, 2023
• Study Start: December 15, 2023
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)