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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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.
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Time frame: evaluated in 24 months since the treatment began
1. Objective response rate (ORR)
Baseline to measured stable disease
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: up to 24 months
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