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

NCT03224221 | Unknown Phase 2

• 1 other identifier: AHAT-103
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma; apatinib

Outcome Measures

Primary Outcomes (1)

• One-year survival rate

  The probability of survival in one year

  12 months

Secondary Outcomes (4)

• Progress free survival（PFS）

  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

• Overall survival

  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

• Incidence of Treatment-Emergent Adverse Events

  Each follow up visit, assessed up to 12 months

• Quality of life using EORTC QLQ C30 - scale

  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

Study Arms (2)

Apatinib with Chemotherapy

EXPERIMENTAL

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

Chemotherapy

ACTIVE COMPARATOR

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

Apatinib DRUG

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

Apatinib with Chemotherapy

fluorouracil and platinum DRUG

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

Apatinib with Chemotherapy; Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, age:≥18 years old.
• Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
• 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).
• The ECOG physical status score: 0 to 2.
• Expected survival ≥ 3 months.
• 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;
• The main organs function properly:
• blood routine examination standards to be met (14 days without blood transfusion and blood products):
• HB≥90g/L;
• ANC≥1.5×109/L;
• PLT≥80×109/L;
• biochemical tests to meet the following criteria:
• TBIL\<1.5×ULN;
• ALT and AST\<2.5×ULN, and \<5×ULN for patients with liver metastases
• Serum Cr≤1.5×ULN or endogenous creatinine clearance\> 45ml/min (Cockcroft-Gault formula);

You may not qualify if:

• Pregnant or lactating women;
• 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;
• Have a significant impact on oral drug absorption factors, such as unable to swallow, chronic diarrhea and intestinal obstruction;
• 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;
• with a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + + above), 6 months of history of gastrointestinal bleeding;
• Central nervous system metastasis with symptoms;
• The investigator judged other circumstances that will affect the conduct of the study and the outcome of the study

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

apatinib; Fluorouracil; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, 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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Guoping Sun, Ph.D.

CONTACT

0551-62922249; gpsun_ahmu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: March 23, 2017
• Primary Completion: January 23, 2019
• Study Completion: June 23, 2019
• Last Updated: July 21, 2017

Record last verified: 2017-06

Locations

CN (1)