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Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal irinotecan | Experimental | liposomal irinotecan With Cisplatin and Concurrent Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Irinotecan Hydrochloride | Drug | liposomal irinotecan With Cisplatin and Concurrent Radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerable dose (MTD) | The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR | Within 28 days of the end of treatment |
| Progress-free survival(PFS) | Progression-free survival will be measured from the start of treatment until the first documentation of confirmed disease progression or death due to any cause, whichever occurs first. |
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Inclusion Criteria:
Understand and be willing to sign written informed consent and be able to follow research protocols for treatment.
Age 18-75 years.
Histologically confirmed cT2-T4a,N0-N+,M0 Esophageal Squamous Carcinoma.
Existence of measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
No previous anti-tumor therapy for esophageal cancer
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥ 3months
Adequate organ and bone marrow function measured within14 days prior to administration of study treatment as defined below:
Haemoglobin ≥ 90g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤institutional upper limit of normal Aspartate aminotransferase (AST(SGOT)/Alanine transaminase (ALT)SGPT) ≤ 2.5 x institutional upper limit of normal Serum creatinine ≤ 1.2mg/dL And creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.
Exclusion Criteria:
patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma.
Allergic to cisplatin.
Patients with a history of esophageal squamous cell carcinoma surgery.
A history of fistula caused by primary tumor infiltration.
Have higher, esophageal fistula or esophageal perforation of gastrointestinal bleeding risk.
Poor nutritional status, BMI < 18.5kg/m2, or PG-SGA score ≥9.
Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment.
Patients with active hepatitis B, hepatitis C, syphilis.
major cardiovascular disease, including any of the following:
Severe prolonged diarrhoea.
Severe mental illness.
Use of strong inhibitors or inducers such as CYP3A4, CYP2C8 and UGT1A1.
Participate in other trials within 4 weeks before the start of the trial.
The investigators believe that patients were inappropriate for participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Wang, Phd | Contact | 13931182128 | wangjunzr@163.com |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 2-years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |