Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

NCT03651219 | Unknown Phase 3

• 1 other identifier: 20171301
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial.

Conditions

Small Cell Lung Cancer

Keywords

SCLC; apatinib; Irinotecan

Outcome Measures

Primary Outcomes (1)

• duration of treatment

  time from take apatinib to withdrawal from experiment due to adverse reaction of apatinib

  two years

Secondary Outcomes (1)

• progress free survival and overall survival

  two years

Study Arms (2)

experimental group

EXPERIMENTAL

Patients use Apatinib Mesylate tablets combined with Irinotecan.

Drug: Apatinib; Drug: Irinotecan

controlled group

ACTIVE COMPARATOR

Patients use Irinotecan

Drug: Irinotecan

Interventions

Apatinib DRUG

Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)

experimental group

Irinotecan DRUG

Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)

controlled group; experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced/metastatic small lung cancer (IIIb / IV) confirmed by pathology with measurable lesions ；
• Patients was treated by platinum chemotherapy drugs and was diagnosed to PD；
• ECOG：0-2；
• Anticipated survival time more than 3 months；
• Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；
• Patients voluntarily entered the study and signed informed consent form (ICF).
• The function in main organs of patients is normal.

You may not qualify if:

• Blend cancer type with NSCLC or else；
• Brain MRI, CT or venography confirmed that there are brain hemorrhage symptoms;
• MRI, CT or venography confirmed that tumor invaded big vessels;
• Patients with uncontrollable hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg, despite optimal drug therapy).；
• Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms)；
• Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy;
• Urine protein≥++, or urine protein in 24 hours≥1.0g;
• Received big surgery, had bone fracture or ulcer in 4 weeks;
• Unhealed bone fracture or wound for long time;
• Patients with active hepatitis B virus or hepatitis C virus infection；
• Patients who received systemic antibiotic treatment of serious infections;
• Pregnant and lactational woman or patients do not receive contraception;
• Patients who are prone to bleed or use anticoagulant drugs.
• Patients who have other uncured malignant tumors.
• Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc；

Sponsors & Collaborators

• Beijing Chest Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinib; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Hui Zhang, Vice Director

CONTACT

010-89509281; bjchzhanghui@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: experimental group: Irinotecan 80mg/m2 d1,d8 vi, apatinib mesylate tablets(250mg/d) po, 4-6 cycle（21d per cycle）; controlled group: Irinotecan 80mg/m2 d1,d8 vi, 4-6 cycle（21d per cycle）;

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 29, 2018
• Study Start: September 8, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2020
• Last Updated: August 29, 2018

Record last verified: 2018-08