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Status unknownNCT03224221Updated Jul 21, 2017

Apatinib Combined With Chemotherapy for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment

A Phase 2 interventional study of Apatinib and fluorouracil and platinum in Esophageal Squamous Cell Carcinoma, sponsored by The First Affiliated Hospital of Anhui Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by The First Affiliated Hospital of Anhui Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2017, registered Jul 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma

Keywords

  • esophageal squamous cell carcinoma
  • apatinib
03

In context

Carcinoma, Squamous Cell

1,774 studies on the registry are indexed under Carcinoma, Squamous Cell; 413 are open to participants now.

This study's planned enrollment of 189 is above the median of 44 across 1,416 interventional studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

The First Affiliated Hospital of Anhui Medical University is the lead sponsor of 42 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    Apatinib with Chemotherapy

    Apatinib with Chemotherapy(Fluorouracil and platinum),patients will receive Apatinib at 500mg/times,oral one times daily for 28 days.the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients

    Drug: Apatinib · Drug: fluorouracil and platinum

  • Active comparator
    Chemotherapy

    Chemotherapy (Fluorouracil and platinum),the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients.

    Drug: fluorouracil and platinum

Interventions

  • DrugApatinib

    Patients will receive Apatinib at 500mg/times,oral one times daily for 28 days

  • Drugfluorouracil and platinum

    the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients

06

What researchers measure

Primary outcomes

  1. One-year survival rate

    The probability of survival in one year

    Time frame: 12 months

Secondary outcomes

  1. Progress free survival(PFS)

    Time frame: 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

  2. Overall survival

    Time frame: 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

  3. Incidence of Treatment-Emergent Adverse Events

    Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment

    Time frame: Each follow up visit, assessed up to 12 months

  4. Quality of life using EORTC QLQ C30 - scale

    Life quality evaluation using EORTC QLQ C30 - scale,once every 1 cycle assessment

    Time frame: 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

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui 230000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03224221
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Responsible party
Sponsor
First posted
Jul 21, 2017
Start date
Mar 23, 2017
Primary completion
Jan 23, 2019 (estimated)
Completion
Jun 23, 2019 (estimated)
Last update
Jul 21, 2017

Study contacts

Guoping Sun, Ph.D.
Contact
gpsun_ahmu@126.com
0551-62922249

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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