Clinical trial NCT03224221: Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
Official title: Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
apatinib
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We conduct the clinical trial to further explore the efficacy and safety of Apatinib combined with chemotherapy in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

Detailed description: Esophageal cancer is one of the most common malignant tumor and esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma in China. Treatment of recurrent or metastatic esophageal squamous cell carcinoma is usually poor. New treatments were needed. Apatinib, which was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer, is a small molecule tyrosine kinase inhibitor. It competes with intracellular VEGFR-2's ATP binding sites highly and selectively, thereby blocking downstream signaling to achieve the goal of inhibiting neovascularization in tumor tissue. We have observed in clinical practice that some patients with esophageal squamous cell carcinoma have benefited from the treatment of apatinib. So we conduct a phase II clinical trial to explore the efficacy and safety of Apatinib combined with chemotherapy (platinum and fluorouracil) in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

Eligibility criteria: Inclusion Criteria:

* 1.Male or female patients, age:≥18 years old.
* 2.Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
* 3.Patients who undergo local or recurrent metastases after surgery and / or radiotherapy and chemotherapy,at least one measurable lesion(tumor lesions CT scan length ≥ 10 mm,lymph node lesions CT scan short diameter ≥ 15 mm,scan layer thickness is not greater than 6 mm).
* 4.The ECOG physical status score: 0 to 2.
* 5.Expected survival ≥ 3 months.
* 6.Subjects received other treatment damage have been restored, which received nitroso or mitomycin interval ≥ 6 weeks; to accept other cytotoxic drugs, radiotherapy or surgery ≥ 4 weeks, and the wound has been completely healed;
* 7.The main organs function properly:

  1. blood routine examination standards to be met (14 days without blood transfusion and blood products):

     1. HB≥90g/L;
     2. ANC≥1.5×109/L;
     3. PLT≥80×109/L;
  2. biochemical tests to meet the following criteria:

     1. TBIL\<1.5×ULN;
     2. ALT and AST\<2.5×ULN, and \<5×ULN for patients with liver metastases
     3. Serum Cr≤1.5×ULN or endogenous creatinine clearance\> 45ml/min (Cockcroft-Gault formula);
* 8.The women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use the appropriate method at 8 weeks after the trial and the last given test contraception.For the man, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given;
* 9.Patients should be voluntary to the trial and provide with signed informed consent

Exclusion Criteria:

* 1.Pregnant or lactating women;
* 2.Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg) with myocardial infarction or myocardial infarction, arrhythmia and grade II heart Incomplete function;
* 3.Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;
* 4.Coagulation dysfunction(INR\>1.5 or prothrombin time (PT)\>ULN + 4 seconds or APTT\>1.5×ULN),with bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
* 5.with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;
* 6.Central nervous system metastasis with symptoms;
* 7.The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study

Primary outcomes:
measure: One-year survival rate
timeFrame: 12 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Overall survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Each follow up visit, assessed up to 12 months
measure: Quality of life using EORTC QLQ C30 - scale
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
References: