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

NCT02976896 | Completed Phase 2 DMC

• 1 other identifier: Poetry-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  6 months

Secondary Outcomes (5)

• 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

• Time to progression

  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 vist, 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 100 months

• Quality of life using esophageal special scale QLQ - OES18

  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

Study Arms (1)

Apatinib Mesylate

EXPERIMENTAL

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

Drug: Apatinib Mesylate

Interventions

Apatinib Mesylate DRUG

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

Apatinib Mesylate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, age:18-75 years old.
• The ECOG physical status score: 0 to 2.
• Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
• Patients who previously received at least fluorouracil, platin or taxane-based palliative chemotherapy but failed(including patients who developed disease progression within half of a year after finishing their adjuvant or neoadjuvant chemotherapy) and patients who are intolerable or refuse to receive chemotherapy of agents mentioned above and develop disease progression within 2 months.
• Never received treatment of apatinib or any other anti-angiogenesis agent, such as sorafenib, sunitinib, bevacizumab, endostar etc.
• Lesions can be measured at single diameter by thoracic or abdominal computed tomography (CT) or magnetic resonance (MRI).Conventional methods should set at least 20mm as diameter or spiral CT 10 mm. Patients with increased or new lesions in radiotherapy area can be enrolled in the trial.
• Expected survival ≥ 3 months.
• If the subject have received surgery, the operative wound should be completely healed and without bleeding tendency.
• Baseline of blood routine and biochemical routine should meet the following criteria:
• ANC≥1.5×10\^9/L（1500/mm3）
• PLT≥75×10\^9/L
• Hb≥9 g/dL
• Serum bilirubin levels no higher than 2 times the upper limit of normal value.
• AST and ALT no higher than 2.5 times the upper limit of normal value(no higher than 5 times the upper limit of normal value when patients developed liver metastasis).
• Serum creatinine no higher than 1.5 times the upper limit of normal value.

You may not qualify if:

• Evidence of gastrointestinal bleeding tendency including: local active ulcer lesions with occult blood (+ +); melena and haematemesis within 2 months; possibilities of digestive tract hemorrhage.
• Evidence of hypertension that could not be controlled by drugs (SBP\>140 mmHg, DBP\>90 mmHg), grade I coronary heart disease, grade I arrhythmia(including QT interval prolonged by 450ms in male and 470ms in female) and grade I heart failure.
• Evidence of severe postoperative complications including intestinal obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis.
• Evidence of urine protein ≥ (++) and 24 hours urinary protein quantitation \>1.0 g.
• Fractures unhealed for long term or incompletely healed.
• Evidence of immunodeficiency disease, or other acquired or congenital immunodeficiency disease, or organ transplantation.
• Evidence of coagulation disorders (INR\>1.5, APTT\>1.5 ULN), bleeding tendency(INR should be in normal value without anticoagulation 14 days before randomization), usage of anticoagulation or Vit K antagonist including warfarin, heparin or any other analogue. When INR≤ 1.5, small dosage of warfarin(1 mg p.o, qd) or Aspirin (dosage \< 100mg/d) in preventive purpose is allowed.
• Known severe hypersensitivity to Apatinib or any of the excipients of this product
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
• CNS metastases without radiotherapy and/or surgery. Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks.
• psychiatric illness that would prevent the patient from giving informed consent
• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
• Patient is concurrently using other approved or investigational antineoplastic agent
• Pregnant or lactating women

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

apatinib

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

Study Officials

• Li Yuhong, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 29, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)