Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT04005170|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Esophageal Cancer||Drug: Toripalimab Drug: Paclitaxel/Cisplatin Radiation: Intensity-modulated radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma|
|Actual Study Start Date :||June 25, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: PD-1 group
All patients will receive standard fractionation radiation therapy (RT) scheme: 50.4 Gy in 28 fractions over 5-6 weeks, concurrently with 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 and 2 cycles of toripalimab 240 mg on days 1, 22 followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
Other Name: JS-001
Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy.
Other Name: TP
Radiation: Intensity-modulated radiotherapy
All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
Other Name: IMRT
- clinical complete response rate [ Time Frame: 3 months after chemoradiotherapy (plus or minus 14 days) ]Tumor response was evaluated 3 months after the completion of chemoradiotherapy based on CT or PET-CT scans, endoscopy with biopsies.
- 2-year overall survival [ Time Frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months ]The 2-year overall survival of the whole group
- 2-year progression-free survival [ Time Frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months ]The 2-year progression-free survival of the whole group
- Duration of response [ Time Frame: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 24 months ]Tumor response was evaluated every two months after chemoradiotherapy according to RECIST criteria
- Incidence of treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From the start of treatment to 2 year after the completion of treatment ]Toxicity of treatment was evaluated according to CTCAE 4.0
- The impact of PD-L1 expression on clinical response [ Time Frame: Baseline biopsies of primary tumor in esophagus ]To investigate the impact of programmed cell death-ligand 1 (PD-L1) expression on clinical response
- The impact of IDO1 expression on clinical response [ Time Frame: Baseline biopsies of primary tumor in esophagus ]To investigate the impact of indoleamine 2,3-dioxygenase 1 (IDO1) expression on clinical response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005170
|Contact: Mian XI, MDemail@example.com|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guanzhou, Guangdong, China, 510060|
|Contact: Mian Xi, MD +86-20-87343385 firstname.lastname@example.org|