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Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766178
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Wang, The First Affiliated Hospital of Zhengzhou University

Brief Summary:
The purpose of this study is to observe and evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Nimotuzumab + SHR-1210 Phase 2

Detailed Description:
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a single-arm, open phase II clinical trial of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Open Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Combined With Nimotuzumab as Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab + SHR-1210
Nimotuzumab + SHR-1210
Drug: Nimotuzumab + SHR-1210

SHR-1210: 200 mg/time, intravenous injection, q2W continuous medication, a course of treatment needs 28 days. The cumulative longest medication period is 2 years.

Nimotuzumab: 200 mg/time, intravenous injection, administered on the 1st and 8th days of each cycle, every 2 weeks is one cycle.





Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 1 year ]
    From date of randomization until the date of death from any cause


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: up to 1 year ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD)

  2. Progression-free Survival (PFS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of first documented progression or date of death from any cause

  3. Duration of response (DOR) [ Time Frame: up to 2 year ]
    Refers to the time when the tumor is first evaluated as CR or PR until the first assessment is PD (Progressive Disease) or any cause of death.

  4. Time to response (TTR) [ Time Frame: up to 1 year ]
  5. Overall survival(OS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause

  6. 9-month survival rate [ Time Frame: up to 9 month ]
  7. 12-month survival rate [ Time Frame: up to 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18~75 years, both men and women.
  2. Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC), and locally advanced unresectable, local recurrence or distant metastasis.
  3. Patients undergoing first-line systemic chemotherapy (which may include platinum, lavender or fluorouracil) progression or intolerance (progress in maintenance therapy after first-line chemotherapy can also be included). Synchronous chemoradiotherapy for postoperative recurrence or metastasis is considered as first-line treatment; For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure.
  4. At least one measurable/evaluable lesion by RECIST v1.1. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1 standard, can also be used as a target lesion).
  5. EGFR immunohistochemistry or FISH detection was positive in tumor tissue samples.
  6. Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved.
  7. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  8. Life expectancy of ≥ 12 weeks.
  9. The main organs function normally, that is, the following criteria are met:

(1) Blood routine examination:

  1. HB≥90g/L;
  2. ANC ≥ 1.5 × 109 / L;
  3. PLT ≥ 80 × 109 / L. (2) Biochemical examination:

a. ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min. 10. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥ normal low limit (50%).

11. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment, and Must be non-lactating; males should agree to use contraceptives during the study period and within 6 months of the end of the study period.

12. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-u.

Exclusion Criteria:

  1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adult; asthma patients who require bronchodilators for medical intervention cannot be included).
  2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose >10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment.
  3. Patients who received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor;
  4. Patients who received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
  5. Patients with brain metastases with symptoms or symptom control for less than 3 months;
  6. Patients with any severe and/or uncontrolled diseases, including patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 480ms) and grade I cardiac insufficiency; active or uncontrolled severe infection; liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copy number / ml or 2000 IU / ml) Or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method);
  7. Imaging studies have shown that the tumor has invaded the important vascular circumference or that the patient is likely to invade the important;
  8. Pregnant or lactating women.
  9. Patients with other malignant tumors within 5 years(Except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured).
  10. Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder.
  11. Patients who have participated in other drug clinical trials within four weeks.
  12. According to the investigator's judgment, the patients with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
  13. Researchers believe that it is not suitable for inclusion. -

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): NCT03766178


Contacts
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Contact: Feng Wang, Doctor 13938244776 fengw010@163.com

Locations
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China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Investigators
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Principal Investigator: Feng Wang, Doctor The First Affiliated Hospital of Zhengzhou University
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Responsible Party: Feng Wang, Doctor, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03766178    
Other Study ID Numbers: FQX-002
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents