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Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04844385
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Hui Liu, Sun Yat-sen University

Brief Summary:
This Phase II randomized study is to determine the efficacy and toxicity of toripalimab plus neoadjuvant chemotherapy combined with chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Toripalimab Drug: Paclitaxel-albumin Drug: Nedaplatin Radiation: SMART Drug: Capecitabine Phase 2

Detailed Description:

This Phase II randomized study is to determine the efficacy and toxicity of toripalimab plus neoadjuvant chemotherapy combined with chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Actual Study Start Date : February 20, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Toripalimab plus Paclitaxel/Nedaplatin followed by concurrent chemoradiotherapy
Patients in experimental group receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, then followed by daily simultaneous modulated accelerated radiotherapy combined with Capecitabine.
Drug: Toripalimab
Toripalimab 240 mg, d1, Q3w for two cycles

Drug: Paclitaxel-albumin
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles

Drug: Nedaplatin
Nedaplatin 75mg/m2, d1, Q3w for two cycles

Radiation: SMART
Once-daily simultaneous modulated accelerated radiotherapy (PTV-GTV: 60Gy/24f )

Drug: Capecitabine
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy




Primary Outcome Measures :
  1. 2-year progression-free survival rate [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. 2-year overall survival rate [ Time Frame: 2-year ]
  2. Clinical response rate [ Time Frame: 2 months after radiotherapy ]
    the percentage of patients who had partial remission or complete remission after therapy

  3. the rate of grade 3 or 4 toxicities according to CTCAE4.0 [ Time Frame: 1 year after therapy ]
    the percentage of patients who develop grade 3 or 4 toxicities

  4. 2-year distant metastasis-free survival [ Time Frame: 2-year ]
  5. 2-year locoregional recurrence-free survival [ Time Frame: 2-year ]
  6. Quality of life assessed by QLQ-C30 [ Time Frame: 2-year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed esophageal squamous cell carcinoma
  • patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • unresectable T2-4 N0-3 M0 confirmed by CT or MRI
  • ECOG performance status 0-1
  • no previous chest radiotherapy, immunotherapy or biotherapy.
  • hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
  • serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
  • bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
  • FEV1 >0.8 L
  • CB6 within normal limits
  • patients and their family signed the informed consents

Exclusion Criteria:

  • previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  • contraindication for chemotherapy
  • women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  • women who has the probability of pregnancy without contraception
  • tendency of hemorrhage
  • in other clinical trials within 30 days
  • addicted in drugs or alcohol, AIDS patients
  • uncontrollable seizure or psychotic patients without self-control ability
  • severe allergy or idiosyncrasy
  • not suitable for this study judged by researchers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844385


Contacts
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Contact: Bo Qiu, Professor +86-020-87343031 qiubo@sysucc.org.cn

Locations
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China, Guangdong
Sun yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Bo Qiu, Professor    020-87343031    qiubo@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hui Liu, Professor Sun yat-sen universtiy cancer center
Publications:

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Responsible Party: Hui Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04844385    
Other Study ID Numbers: GASTO-1071
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Liu, Sun Yat-sen University:
Toripalimab, Neoadjuvant, Concurrent Chemoradiotherapy, Esophageal Squamous Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Capecitabine
Nedaplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites