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This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+ Paclitaxel+ Cisplatin | Experimental | The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation). At the end of the treatment, the patients were followed up for safety and effectiveness. |
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| Camrelizumab+ Albumin bound paclitaxel+ Cisplatin | Experimental | The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation). At the end of the treatment, the patients were followed up for safety and effectiveness. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab+Albumin bound paclitaxel+Cisplatin | Drug | Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| biomarkers related to pCR | t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1. | 9 weeks |
| Disease Control Rate | Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated. |
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Inclusion Criteria:
Age: 18-75 years old, male or female;
Esophageal squamous cell carcinoma was confirmed by pathology (except for cervical and Suprathoracic tumors that could not be operated);
Patients with resectable esophageal squamous cell carcinoma with clinical stage T3-T4a or TxN + M0 (except T4b);
ECOG PS score was 0-1;
There was at least one measurable lesion (according to recist1.1) or unmeasurable lesion that could be evaluated, and the imaging diagnosis time was ≤ 21 days;
The expected survival time was more than 3 months;
The function of the main organs was normal, and there were no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency diseases. The laboratory examination meets the following requirements:
There was no active bleeding or thrombosis
The patients with normal or mild to moderate abnormal lung function (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco> 40%) could tolerate esophagectomy;
The fertile female subjects were required to conduct blood pregnancy test within 72 hours before the first administration, and the result was negative, and voluntarily used appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug; For men, surgical sterilization or consent to appropriate contraceptive methods during the observation period and within 90 days after the last administration of the study drug should be used.
The subjects voluntarily joined the study and signed the informed consent form (ICF);
The patients with good compliance were expected to follow up the efficacy and adverse events / reactions according to the protocol requirements.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of GI Oncology, Peking University Cancer Hospital, | Beijing | Beijing Municipality | 100142 | China |
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| Camrelizumab+ Paclitaxel+ Cisplatin | Drug | Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks. |
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| 9 weeks |
| Disease free survival | The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment. | Time from randomization to patient's tumor progression or death |
| Overall Survival | OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier | The time from the beginning of randomization to death due to any cause. |
| Safety | Adverse events | from first treatment to 90 days after esophagectomy |