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The primary reason for termination was difficulty in recruitment
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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 assessment to change the following chemoradiotherapy regiment for locally advanced unresectable ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-CT responders | Experimental | SUV (PETr) reduction >35% |
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| PET-CT non-responders | Experimental | SUV (PETr) reduction ≤35% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab+TP/FP+ radiation therapy | Drug | Induction stage: Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Objective response rate (ORR) | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 24 monthss |
| 2. Duration of Overall Response(DoR) | The duration of overall response is measured from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented. |
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Inclusion Criteria:
1.Age 18-75 years old, both men and women; 2.Histopathology confirmed as esophageal squamous cell carcinoma,stage II-IVa:T1N2-3M0,T2-4bN+M0; 3.If technically feasible, all patients are recommended to have local staging determined by endoscopic ultrasound (EUS); The endoscopic examination report or gastrointestinal (GI) clinical records should clearly indicate the T and N stages; Perform PET-CT examination; 4.Except for basal or squamous cell skin cancer, bladder cancer in situ or cervical cancer, there is no history of malignant tumor within 5 years; Patients with malignant tumors who have undergone surgical treatment in the past and those who have survived disease-free for more than 5 years meet the inclusion criteria; 5.Have not received any systemic anti-tumor treatment in the past (systemic chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) 6.According to RECIST 1.1, at least one measurable lesion; 7.ECOG: 0~1; 8.Expected survival period ≥ 12 weeks; 9.Major organ function has to meet the following certeria:
Blood routine examination:
Biochemical examination:
Exclusion Criteria:
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|
| Adebrelimab+FP/TP+ radiation therapy | Drug | Induction stage: Adebrelimab : 1200mg d1, iv, q3w TP : nab-paclitaxel paclitaxel 180mg/m2, or paclitaxel 135-175mg/m2, d1, iv; carboplatin AUC=5-6, d1, iv, q3w FP : fluorouracil 400mg/m2, 2400 mg/m2 (48 hours), d1; cisplatin 75mg/m2, d1, iv, q3w 2 cycles; Treatment stage: (switch to a different chemotherapy drug which not used during the earlier induction phase) FP : fluorouracil 300mg/m2/d, iv; cisplatin 75mg/m2, d1, iv, q3w TP : nab-paclitaxel paclitaxel 60-70mg/m2, or paclitaxel 75mg/m2, d1, iv; carboplatin AUC=5, d1, iv, q3w Radiation therapy (50.4Gy-60Gy/28-33f); Consolidation stage: Adebrelimab: 1200mg d1, iv, q3w , until disease progression or unacceptable toxicity occurs. |
|
| tumor assessment every 6 weeks since the treatment began,up to 24 months |
| 3. Overall survival (OS) | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months |
| 4. Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit. | up to 24 months |
| 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 |
| 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 |
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