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

NCT ID: NCT03946969

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2022-10-31

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1

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

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

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

Liposomal Paclitaxel + Cisplatin + S-1

Intervention Type: DRUG

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.

Interventions

Sintilimab

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

Intervention Type: DRUG

Liposomal Paclitaxel + Cisplatin + S-1

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.

Intervention Type: DRUG

Other Intervention Names

IBI308; PFC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Gu Yanhong

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanhong Gu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

References

Chen X, Xu X, Wang D, Liu J, Sun J, Lu M, Wang R, Hui B, Li X, Zhou C, Wang M, Qiu T, Cui S, Sun N, Li Y, Wang F, Liu C, Shao Y, Luo J, Gu Y. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial. J Immunother Cancer. 2023 Feb;11(2):e005830. doi: 10.1136/jitc-2022-005830.

Reference Type: DERIVED

PMID: 36759013 (View on PubMed)

Other Identifiers

KEEP-G 03

Identifier Type: -

Identifier Source: org_study_id