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Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma | Drug: Sintilimab Drug: Liposomal Paclitaxel + Cisplatin + S-1 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 8, 2019 |
| Estimated Primary Completion Date : | December 2020 |
| Estimated Study Completion Date : | October 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sintilimab + Liposome Paclitaxel + Cis-Platinum + S-1
Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.
|
Drug: Sintilimab
Sintilimab 200mg ivd d1, repeated every 3 weeks for two cycles.
Other Name: IBI308
Drug: Liposomal Paclitaxel + Cisplatin + S-1 Liposomal Paclitaxel 135mg/m2 ivd d1 + Cisplatin 25mg/m2 ivd d1-3 + S-1 40mg capsule po d1-14, repeated every 3 weeks for two cycles.
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- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 20 months ]From the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. To evaluate the incidence of TEAE, rate of grade 3 and 4 TEAE (CTCAE 5.0), rate of surgery delay over 30 days and/or inoperable patients.
- Major Pathological Response (MPR) rate [ Time Frame: 20 months ]MPR is defined as 10% or fewer viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor following neoadjuvant treatment.
- Rate of R0 Resection [ Time Frame: 20 months ]R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin.
- Objective Response Rate (ORR) [ Time Frame: 20 months ]Objective response rate is defined as the rate of patients with at least a 30% decrease in the sum of the LD (longest diameter) of target lesions, which include complete response (CR) or partial response (PR).
- Recurrence Free Survival (RFS) [ Time Frame: 5 years ]From from surgery to the date of recurrence or death.
- Overall Survival [ Time Frame: 5 years ]From the begin of neoadjuvant treatment until the date of death from any cause.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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-3N1-3M0).
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.
| Contact: Yanhong Gu, Dr | 00862568306714 | guluer@163.com | |
| Contact: Xiaofeng Chen, Dr | 008613585172066 | xiaofengch198019@126.com |
| China, Jiangsu | |
| The First Affiliated Hospital with Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210000 | |
| Contact: Yanhong Gu, Dr. 00862568136714 guluer@163.com | |
| the First Affiliated Hospital of Nanjing Medical University | Recruiting |
| Nanjing, Jiangsu, China, 210029 | |
| Contact: Yanhong Gu, Ph.D 13813908678 guluer@163.com | |
| Principal Investigator: Yanhong Gu, Ph.D | |
| Principal Investigator: | Yanhong Gu | The First Affiliated Hospital with Nanjing Medical University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 9, 2019 | ||||||||
| First Posted Date ICMJE | May 13, 2019 | ||||||||
| Last Update Posted Date | January 14, 2020 | ||||||||
| Actual Study Start Date ICMJE | May 8, 2019 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 20 months ] From the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. To evaluate the incidence of TEAE, rate of grade 3 and 4 TEAE (CTCAE 5.0), rate of surgery delay over 30 days and/or inoperable patients.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 liposome paclitaxel, cis-platinum 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Esophageal Squamous Cell Carcinoma | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: Sintilimab + Liposome Paclitaxel + Cis-Platinum + S-1
Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
40 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 2022 | ||||||||
| Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
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-3N1-3M0). 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. |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03946969 | ||||||||
| Other Study ID Numbers ICMJE | KEEP-G 03 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Gu Yanhong, The First Affiliated Hospital with Nanjing Medical University | ||||||||
| Study Sponsor ICMJE | The First Affiliated Hospital with Nanjing Medical University | ||||||||
| Collaborators ICMJE | Innovent Biologics (Suzhou) Co. Ltd. | ||||||||
| Investigators ICMJE |
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| PRS Account | The First Affiliated Hospital with Nanjing Medical University | ||||||||
| Verification Date | January 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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