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A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib

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ClinicalTrials.gov Identifier: NCT03787251
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Ren, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:
A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Drug: Apatinib Drug: The chemotherapeutic drug chosen by the investigator. Phase 2

Detailed Description:
This is a randomized, open-label, multi-center, phase II clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.
Drug: Apatinib
It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.

Active Comparator: Control group

The chemotherapeutic drug chosen by the investigator (if not used in the previous treatment regimen, it cannot be selected).

The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.

In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient decease. If the adverse event grade 3 and above Or non-hematologic toxicity of grade II and above appeared, allowing the dose to be lowered twice.

Drug: The chemotherapeutic drug chosen by the investigator.

The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.

In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice.





Primary Outcome Measures :
  1. PFS [ Time Frame: One year from admission ]
    progression-free survival


Secondary Outcome Measures :
  1. OS [ Time Frame: One year from admission ]
    Overall Survival

  2. DCR [ Time Frame: One year from admission ]
    disease control rate

  3. ORR [ Time Frame: One year from admission ]
    Objective Response Rate



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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:

  • Pathological/histological diagnosis of esophageal squamous cell carcinoma; and at least one measurable lesion according to RECIST criteria (version 1.1);
  • Patients who have undergone radical resection of esophageal cancer and who have failed after first-line systemic chemotherapy (which may include platinum, taxane or fluorouracil) after recurrence (recurrence of postoperative adjuvant chemotherapy within 6 months) Considered as first-line treatment, and the same progress in the field of radiation can be seen as recurrence;
  • Age: 18-75 years old; both men and women;
  • ECOG PS Rating: 0-1 points;
  • Estimated survival period ≥ 3 months;
  • ≥ 4 weeks from the last cytotoxic drug;
  • The main organs function normally, that is, meet the following criteria:

    • Blood routine examination:

      • HB≥90 g/L; (no blood transfusion within 14 days)
      • ANC ≥ 1.5 × 109 / L;
      • PLT ≥ 80 × 109 / L;
    • Biochemical examinations must meet the following criteria:

      • ALT and AST < 2.5 ULN; if there is liver metastasis, ALT and AST < 5 ULN;
      • TBIL ≤ 1.5ULN;
      • Plasma Cr≤1.5ULN or creatinine clearance (CCr)≥60ml/min
  • Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
  • 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; negative serum or urine pregnancy tests within seven days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

  • Those who have used anti-tumor angiogenesis drugs to treat failure;
  • Patients with residual esophagus, residual stomach or anastomotic recurrence;
  • Unable to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs;
  • Patients with brain metastases with symptoms or symptoms controlled for less than 3 months;
  • Long-term unhealed wounds and fractures;
  • Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood above ++), history of gastrointestinal bleeding within 6 months; coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg< 2 g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • Overactive/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;
  • Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding.
  • Persons with a history of psychotropic substance abuse who are unable to resolve or have a mental disorder;
  • Participated in other clinical trials of anti-tumor drugs within four weeks;
  • Have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
  • According to the investigator's judgment, there are serious concomitant illnesses that compromise the safety of the patient or affect the patient's completion of the study.
  • Patients with any severe and/or uncontrolled diseases, including:

    • Blood pressure control is unreasonable (retraction pressure >150mmHg, diastolic pressure >100mmHg) Patients: I have myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval >440ms) and grade I cardiac insufficiency;
    • Active or uncontrolled serious infections;
    • Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;
    • Poor diabetes control (fasting blood glucose FBG>10mmol/L);
    • Urine routine indicates urinary protein >++, and confirmed 24-hour urine protein quantitation >1.0g.
  • The investigator believes that it is not suitable for inclusion.

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Responsible Party: Wei Ren, Deputy Chief Physician, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03787251     History of Changes
Other Study ID Numbers: Nanjing Drum Tower Hospital
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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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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Recurrence
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms
Disease Attributes
Pathologic Processes
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action