Phase II trail of docetaxel and ramucirumab combination therapy as second-line treatment in patients with metastatic or advanced gastric cancer (HGCSG1903)

JRCT ID: jRCTs011200010

Registered date:18/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 01/02/2021
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Patients recieve docetaxel and ramucirumab combination chemotherapy.

Outcome(s)

• Primary Outcome: Response rate

Secondary Outcome

progression free survival
overall survival
safety
dose intensity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Confirmed stage IV or recurrent gastric adenocarcinoma that is refractory or intolerant to initial chemotherapy.
2.Age of 20 years or older.
3.ECOG PS scale 0-1.
4.No history of treatment with docetaxel.
5.Confirmation of the progression or recurrence following initial treatment and potential presence of an evaluable lesion less than 28 days before registration using CT or MRI findings, according to RECIST version 1.1. Presence of a measurable lesion is an inclusion criterion.
6.Last day of initial chemotherapy administration is more than 14 days before registration.
7. Fulfillment of the standards related to major organ functions within 14 days before registration.Hematolog ical status: neutrophils(ANC)>=1.5x109/L; platelets >=100x109/L; haemog lobin >=9g /dL, Adequate renal function: serum creatinine level <=1.5 x upper normal limit(ULN)or Ccr >=40mL/min, Adequate liver function: serum bilirubin <=1.5 x ULN, AST/ALT< 3 x the ULN for the reference lab
8. Patients who do not have uncontrolled thromboembolism (regardless of whether patients are taking anticoagulants or antiplatelets)
9.Patients who are negative for HER-2/neu and those with unknown HER-2/neu status are eligible. HER-2/neu-positive patients are eligible if they received treatments including trastuzumab and if the disease progress is confirmed.
10. Available written informed consent.
11. Have an estimated life expectancy of >12 weeks in the judgment of the investigator.
12. The patient, if female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method (failure rate < 1%) during and for 12 weeks after the treatment period. If the patient is men, effective contraceptive methods should be able to continue after contraceptive surgery or during the study treatment period and up to 6 months after completion.

Exclude criteria

1.The patient has a history of DVT, PE, or any other significant thromboembolism during the 3 months prior to registration(venous port or catheter thrombosis or superficial venous thrombosis not considered significant thromboembolism).
2.Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
3.Diagnosis of arterial hypertension that cannot be controlled with standard medical management.
4. The patient has a serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to first dose of protocol therapy.
5.Primary cancers diagnosed within the previous five years.
6. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia.
7.The patient has experienced any arterial thrombotic event within 6 months prior.
8. Serious complications or comorbidities.
9.The patient has experienced any Grade 3-4 GI bleeding within 3 months prior.
10. History of gastrointestinal perforation and/or fistulae within 6 months prior.
11.Pericardial or pleural effusion or ascites requiring treatment including drainage.
12. Pregnancy, breast-feeding, or plans of pregnancy.
13.Local or systemic active infection requiring treatment (however, even if the patient's HBsAg is positive, if the disease state is controlled by a nucleic acid analog and HBV-DNA negative is confirmed, the patient can be registered).
14. Patients who are on study treatment or have been treated with the study drug within 28 days before enrollment or are participating in other intervention clinical trials. Patients enrolled in an intervention-free observational study are eligible.
15.Patients with a history of allergy to the study drug or severe hypersensitivity to the components contained in the study drug such as polysorbate 80.
16. The patient has: cirrhosis at a level of Child- Pugh B (or worse) or cirrhosis and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
17.Patients who cannot undergo contrast-enhanced CT examination due to contrast agent allergy.
18. Participation in the clinical trial is determined as unsuitable.

Related Information

• Primary Sponsor: Komatsu Yoshito
• Secondary Sponsor: HOKKAIDO GASTROINTESTINAL CANCER STUDY GROUP (HGCSG)