A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Prospective, Open-label, Randomized, Phase II Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy Versus Chemotherapy in Perioperative Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma (ECTOP-2006).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152978
• Other study ID #: ECTOP-2006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 15, 2023
• Est. completion date: December 15, 2027

Study information

• Verified date: November 2023
• Source: Fudan University
• Contact: Haiquan Chen, MD
• Phone: +86 13601973588
• Email: hqchen1[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was designed as an open-label, randomized controlled, phase II trial. Subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. The primary endpoint is 1-year Event-free survival (EFS) rate.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: December 15, 2027
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	R0 surgery rate	R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.	20 months
Secondary	pCR rate	Pathological Complete Response (pCR) is defined as no viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor and lymph nodes following neoadjuvant treatment.	20 months
Secondary	Disease-free survival (DFS)	DFS is calculated from R0 surgery to the date of recurrence or metastases or death in subjects with radical resection.	24 months
Secondary	Overall Survival (OS)	OS is calculated from the randomization to the date of death from any cause.	24 months
Secondary	adverse events	The incidence of treatment-related adverse events (TRAEs), severe adverse events (SAE), based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0	24 months