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Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

NCT ID: NCT03985670

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2023-04-30

Brief Summary

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The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.

Detailed Description

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The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.

Conditions

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Squamous Cell Carcinoma Esophageal Cancer Perioperative Period

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1

Group Type EXPERIMENTAL

teripalimab plus chemotherapy

Intervention Type DRUG

teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1

chemotherapy followed by immunotherapy

paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3

Group Type ACTIVE_COMPARATOR

chemotherapy plus teripalimab

Intervention Type DRUG

paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3

Interventions

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teripalimab plus chemotherapy

teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1

Intervention Type DRUG

chemotherapy plus teripalimab

paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3

Intervention Type DRUG

Other Intervention Names

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teripalimab and chemotherapy given on the same day chemotherapy followed by teripalimab

Eligibility Criteria

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Inclusion Criteria

* Thoracic esophageal squamous cell carcinoma diagnosed by pathology
* no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
* ECOG score 0-1
* clinical stage is stage II, III, and IVa according to AJCC 8.0
* expected lifespan \> 3 months
* enough organ function
* normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
* the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
* no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
* no history of other malignant tumors
* women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
* The patient agrees to participate in the clinical study and sign the Informed Consent Form.

Exclusion Criteria

* suffering from serious infectious diseases within 4 weeks before enrollment;
* patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
* usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction \<50%
* severe allergies
* severe mental disorder
* abnormal blood coagulation function (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
* previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
* other situations evaluated by investigators not meet the enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Ding, Master

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

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Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Quanli Gao, Dr.

Role: CONTACT

Phone: +86-15038171966

Email: [email protected]

Lingdi Zhao, Dr.

Role: CONTACT

Phone: +86-371-65587483

Email: [email protected]

Facility Contacts

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Quanli Gao, M.D

Role: primary

Lingdi Zhao, M.D.

Role: backup

References

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Xing W, Zhao L, Zheng Y, Liu B, Liu X, Li T, Zhang Y, Ma B, Yang Y, Shang Y, Fu X, Liang G, Yuan D, Qu J, Chai X, Zhang H, Wang Z, Lin H, Liu L, Ren X, Zhang J, Gao Q. The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer-A Phase II Study. Front Immunol. 2021 Dec 6;12:772450. doi: 10.3389/fimmu.2021.772450. eCollection 2021.

Reference Type DERIVED
PMID: 34938292 (View on PubMed)

Xing W, Zhao L, Fu X, Liang G, Zhang Y, Yuan D, Li Z, Gao Q, Zheng Y; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma. J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198.

Reference Type DERIVED
PMID: 33282388 (View on PubMed)

Other Identifiers

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HenanCH immunotherapy001

Identifier Type: -

Identifier Source: org_study_id