Back to results

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sintilimab

Liposomal Paclitaxel + Cisplatin + S-1

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Neoadjuvant, Esophageal Cancer, PD-1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed esophageal squamous cell carcinoma.

The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).

No prior treatment for this disease.

Eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.

Understand and voluntarily sign the informed consent(s).

Patients who are able to complete the treatment and follow-up according to the study plan.

Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.

Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.

Exclusion Criteria:

Patients who may develop tracheoesophageal fistula or aortoesophageal fistula.

Patients suffering from severe malnutrition or needing tube feeding.

Uncured patients with other malignancies within 2 years.

Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.

Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.

Patients who have immune deficiency.

Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.

Patients with uncontrolled diabetes mellitus.

Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.

Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .

Patients who have received allogeneic organ or stem cell transplants.

Patients who are allergic to drugs or related ingredients in this study.

Patients who take part in clinical trials of other drugs or biological therapy at present.

Patients with any serious or unstable medical condition or mental illness.

Patients who are dependent on or addicted to alcohol or drugs.

Sites / Locations

The First Affiliated Hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1

Arm Description

Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.

Outcomes

Primary Outcome Measures

Safety and feasibility

Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.

Secondary Outcome Measures

MPR rate

Major Pathological Response (MPR) is defined as the presence of 10% or fewer viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor following neoadjuvant treatment.

R0 resection rate

R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.

Recurrence-Free Survival (RFS)

Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.

Overall Survival (OS)

Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.

Full Information

NCT ID

NCT03946969

First Posted

May 9, 2019

Last Updated

July 16, 2022

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03946969

Brief Title

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

Official Title

Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 9, 2019 (Actual)

Primary Completion Date

November 9, 2021 (Actual)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

Detailed Description

This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

Keywords

Neoadjuvant, Esophageal Cancer, PD-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1

Arm Type

Experimental

Arm Description

Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

IBI308

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Liposomal Paclitaxel + Cisplatin + S-1

Other Intervention Name(s)

PFC

Intervention Description

Liposomal Paclitaxel (135mg/m2), ivd, d1 + Cisplatin (25mg/m2), ivd, d1-3 + S-1 capsule (40mg), po, d1-14, repeated every 3 weeks for two cycles.

Primary Outcome Measure Information:

Title

Safety and feasibility

Description

Time Frame

20 months

Secondary Outcome Measure Information:

Title

MPR rate

Description

Time Frame

20 months

Title

R0 resection rate

Description

R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.

Time Frame

20 months

Title

Recurrence-Free Survival (RFS)

Description

Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.

Time Frame

5 years

Title

Overall Survival (OS)

Description

Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Exploratory Outcomes

Description

Correlation between biomarkers, including tumor mutational burden (TMB), clonal mutations, genetic alterations, and circulating tumor DNA (ctDNA), and therapeutic response to neoadjuvant therapy will be explored.

Time Frame

20 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed esophageal squamous cell carcinoma. The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0). No prior treatment for this disease. Eastern cooperative oncology group (ECOG) performance status of 0 to 1. Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol. Understand and voluntarily sign the informed consent(s). Patients who are able to complete the treatment and follow-up according to the study plan. Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis. Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study. Exclusion Criteria: Patients who may develop tracheoesophageal fistula or aortoesophageal fistula. Patients suffering from severe malnutrition or needing tube feeding. Uncured patients with other malignancies within 2 years. Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases. Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs. Patients who have immune deficiency. Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy. Patients with uncontrolled diabetes mellitus. Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis. Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) . Patients who have received allogeneic organ or stem cell transplants. Patients who are allergic to drugs or related ingredients in this study. Patients who take part in clinical trials of other drugs or biological therapy at present. Patients with any serious or unstable medical condition or mental illness. Patients who are dependent on or addicted to alcohol or drugs.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanhong Gu

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital with Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

We'll reach out to this number within 24 hrs