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

NCT ID: NCT03224221

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-23
• Study Completion Date: 2019-06-23

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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

fluorouracil and platinum

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

fluorouracil and platinum

Intervention Type: DRUG

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

Interventions

Apatinib

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guoping Sun, Ph.D.

Role: CONTACT

gpsun_ahmu@126.com

0551-62922249

Facility Contacts

Guoping Sun

Role: primary

gpsun_ahmu@126.com

0551-62922249

Other Identifiers

AHAT-103

Identifier Type: -

Identifier Source: org_study_id