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This study aims to evaluate the efficacy and safety of induction Adebrelimab (anti-PD-L1 antibody) combined with chemotherapy, then guided by PET-CT or RECIST1.1 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Induction stage:Adebrelimab+TC; Treatment stage: TC/PF+ radiation therapy; Maintenance stage: Adebrelimab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction stage:Adebrelimab+TC;Treatment stage: TC/PF+ radiation therapy;Maintenance stage: Adebrelimab | Drug | Induction stage:Adebrelimab+TC: Adebrelimab : 1200mg d1, iv, q3w ; TC : paclitaxel 135mg/m2, or nab-paclitaxel paclitaxel 180mg/m2, d1, iv,carboplatin AUC=5, d1, iv, q3w,2 cycles. Treatment stage: TC/PF+ radiation therapy: PET-CT responders (SUV (PETr) reduction ≥35%): TC/PF+ radiation therapy: TC : paclitaxel 50mg/m2, nab-paclitaxel paclitaxel 60mg/m2, d1, iv; carboplatin AUC=2, d1, iv, qw,5 cycles. PF : fluorouracil 750-1000mg/m2, CIV 96 hours,cisplatin 75mg/m2, d1, iv, q4w,2 cycles. Radiation therapy: 50.4Gy-60Gy/28-33f. PET-CT non-responders (SUV (PETr) reduction <35%):(switch to a different chemotherapy drug which not used during the earlier induction phase) PF/TC+ radiation therapy: dose same as above. Maintenance stage: Adebrelimab: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs(Up to one year). |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression-Free-Survival (PFS) rate | PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| cCR rate | A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions. | 12 months |
| Objective Response Rate, ORR | Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| 12 months |
| Disease Control Rate, DCR | Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1. | 12 months |
| Duration of Response, DoR | Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause. | 12 months |
| Progression free Survival, PFS | PFS defined as the time from the date of treatment to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. | 24 months |
| Overall survival, OS | Defined as the time between signing the informed consent form to death due to various causes. | 24 months |
| Incidence of adverse events | Use NCI-CTCAE version 5.0 for classification and grading. | 24 months |