Apatinib Plus Irinotecan as Second-line Treatment in AGC or EGJA

NCT03116555 | Unknown Phase 2 DMC

• 1 other identifier: CLOG0103
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, single-group clinical study of Apatinib Plus Irinotecan as second-line treatment in locally advanced or metastatic gastric or gastroesophageal junctional adenocarcinoma.

Conditions

Metastatic Gastric Adenocarcinoma

Keywords

Apatinib; Irinotecan; Second-line; Metastatic Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival [PFS]

  Progression Free Survival

  5-6 months

Secondary Outcomes (3)

• Overall Survival [OS]

  12-15 months

• Objective Response Rate [ORR]

  12-15 months

• Disease Control Rate [DCR]

  12-15 months

Other Outcomes (3)

• Incidence and Degree of Treatment-Emergent Adverse Events [Safety and Tolerability]

  12-15 months

• Performance Status [WHO-ECOG]

  12-15 months

• Quality of Life [WHO-QOL]

  12-15 months

Study Arms (1)

Irinotecan plus apatinib

EXPERIMENTAL

Irinotecan: 180mg/m2, ivgtt,given on the first day; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day). Repeat the therapeutic schedule every 3 weeks till progressive disease or intolerable toxicities.

Drug: Apatinib; Drug: Irinotecan

Interventions

Apatinib DRUG

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).

Irinotecan plus apatinib

Irinotecan DRUG

Irinotecan was used as second line treatment with AGC

Irinotecan plus apatinib

Eligibility Criteria

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

You may qualify if:

• Age：18-70，female or male.
• Pathologically diagnosed local advanced or metastatic stomach or gastroesophageal junction with adenocarcinoma, at least one measurable objective tumor lesion by spiral CT examination（according to RECIST 1.1）.
• First-line application of fluorouracil-based chemotherapy failed (treatment failure definition: toxic side effects can not tolerate the progress of the disease during treatment or recurrence after treatment); Note:(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant/neoadjuvant therapy was allowed; adjuvant/neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
• UGT1A1\*28(6/6) and \*6(G/G) ,or UGT1A1\*28(6/6) and \*6(G/A),or UGT1A1\*28(6/7) and \*6(G/G).
• ECOG performance status 0-1.
• satisfactory main organ function，laboratory test must meet the following criteria: (1) blood routine examination standards to meet: A. HB≥90g/L; B. ANC≥1.5×109/L; C. PLT≥90×109/L; (2) biochemical tests to meet the following criteria: A. Total bilirubin≤1.5 times the upper limit of normal (ULN) B. ALT and AST≤2.5ULN; C. Serum Cr≤1ULN, endogenous creatinine clearance\> 60ml/min (Cockcroft-Gault formula)
• The international normalized ratio (INR) ≤ 1.5 and some prothrombin time (PPT or APTT) ≤ 1.5ULN within 7 days before participating.
• Expected survival≥3 months;
• Signed informed consent (ICF) before admission;
• Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, contraception should be used for surgical sterilization, or agreed to use the appropriate method 8 weeks after the trial and the last given test drug.

You may not qualify if:

• Hypersensitivity to apatinib, irinotecan or excipients.
• More than one chemotherapy regimen was treated after progression of gastric cancer (except for adjuvant/neoadjuvant chemotherapy with more than 24 weeks of clearance).
• Prior exposure to irinotecan.
• Prior exposure to irinotecan VEGFR inhibitors, such as apotinib, sorafenib, sunitinib.
• Another primary tumor in patients, except for: systematically treatment non-melanoma skin cancer, effectively treatment cervical carcinoma in situ, or other effectively treatment tumors wtih no recurrence for more than 5 years.
• Anti neoplastic cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin 2 or interferon), or other research drugs have been use within 4 weeks before participating.
• Uncontrolled hypertention with systolic blood pressure\> 140 mmHg or diastolic blood pressure\> 90 mmHg, grade I or more coronary heart disease, grade I arrhythmia (including QTc interval: male\> 450 ms, female\> 470 ms) and grade I cardiac insufficiency.
• Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1g.
• Any toxicity more than 1 grade(according to CTCAE) caused by previous treatment, except hair loss.
• Occasional artery/venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurred within 12 months before participation;
• Intestinal obstruction occurred 4 weeks before participation.
• Patients who underwent major surgery 4 weeks prior to initiation of treatment. The patient must be cured from any major surgery.
• Patients who are considered to have a greater risk of medical care due to a serious, uncontrollable disease, non-metastatic systemic disease or active, uncontrollable infection. Some examples include, but not exclusively, uncontrolled ventricular arrhythmias, recent (3 months) myocardial infarction, uncontrollable epilepsy seizures, unstable spinal cord compression, superior vena cava syndrome, HRCT tips Bilateral interstitial lung disease or any mental illness that may obstruct informed consent.
• Immunocompromised patients, for example, serological tests suggest that human immunodeficiency virus (HIV) is positive.
• Pregnant or lactating women.

Sponsors & Collaborators

• China Medical University, China: lead
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Shengjing Hospital: collaborator
• General Hospital of Shenyang Military Region: collaborator
• The People's Hospital of Liaoning Province: collaborator
• Anshan Tumor Hospital: collaborator
• Benxi Cental Hospital: collaborator
• Liaoyang Central Hospital: collaborator
• The Affiliated Tumor Hospital of Harbin Medical University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• Panjin Central Hospital: collaborator
• Jilin University Sino-Japanese Friendship Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Liaoyang Petrochemical General Hospital: collaborator

Study Sites (1)

The First Hospital of China Medical University

Shenyang, Liaoning, 110010, China

RECRUITING

Related Publications (5)

• Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

  PMID: 21296855 RESULT

• Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR; Upper Gastrointestinal Clinical Studies Group of the National Cancer Research Institute of the United Kingdom. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008 Jan 3;358(1):36-46. doi: 10.1056/NEJMoa073149.

  PMID: 18172173 RESULT

• Catalano V, Graziano F, Santini D, D'Emidio S, Baldelli AM, Rossi D, Vincenzi B, Giordani P, Alessandroni P, Testa E, Tonini G, Catalano G. Second-line chemotherapy for patients with advanced gastric cancer: who may benefit? Br J Cancer. 2008 Nov 4;99(9):1402-7. doi: 10.1038/sj.bjc.6604732.

  PMID: 18971936 RESULT

• Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5.

  PMID: 23918952 RESULT

• Thuss-Patience PC, Kretzschmar A, Bichev D, Deist T, Hinke A, Breithaupt K, Dogan Y, Gebauer B, Schumacher G, Reichardt P. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011 Oct;47(15):2306-14. doi: 10.1016/j.ejca.2011.06.002.

  PMID: 21742485 RESULT

MeSH Terms

Interventions

apatinib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• YunPeng Liu, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YunPeng Liu, PhD

CONTACT

86-24-83282312; cmuliuyunpeng@hotmail.com

Xiujuan Qu, PhD

CONTACT

86-24-83282542; qu_xiujuan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology，The First Hospital of China Medical University

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 17, 2017
• Study Start: April 5, 2017
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

CN (1)