Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer

NCT03954756 | Unknown Phase 2

• 1 other identifier: APD-L0315
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Purpose of This Study is to Evaluate the Efficacy and Safety of Apafitini Combined With PD1 in Patients With Advanced Gastric Cancer After Second-line Treatment Failure, Thus Providing More Options for Patients With Advanced Gastric Cancer.

Conditions

Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  up to 2 year

Secondary Outcomes (3)

• Objective response rate

  up to 2 year

• Disease control rate

  up to 2 year

• Overall survival

  up to 2 year

Study Arms (1)

apatinib and PD-1

EXPERIMENTAL

Every patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effect

Drug: Apatinib and PD1

Interventions

Apatinib and PD1 DRUG

1. Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal 2. PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

apatinib and PD-1

Eligibility Criteria

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

You may qualify if:

• Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
• To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.
• Failure of the second-line standard treatment regimen (disease progression), \>14 days from the last chemotherapy, chemotherapy regimen including fluorouracil (5-FU / capecitabine / teggio), oxaliplatin and irinotecan; Acceptable or not received bevacizumab/cetuximab/regofenib treatment.
• Aged 18-70 years old, both genders.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
• Life expectancy of at least 3 months.
• Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.If the lesion receiving local therapy (radiotherapy, radiofrequency, interventional therapy, etc.) is the only lesion, definite imaging progress is required.
• the main organ functions of the patient shall meet the following standards within 7 days before treatment：Blood routine examination standard (without blood transfusion within 7 days before enrollment）Hemoglobin ≥ 70 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ PLT）≥80×109/L；Biochemical examination shall meet the following standards:serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN)；Serum creatinine (Cr)≤1.5ULN or creatinine removal rate (CCr)≥60ml/min；
• Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period。

You may not qualify if:

• Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg；
• Diabetes blood sugar control is poor；
• Acute phase of cerebral infarction, or recovery period \<2 months；
• Has a variety of factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
• Coagulation abnormalities （INR\>1.5×ULN，APTT\>1.5×ULN）,with bleeding tendency;
• Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation \> 1.0 g；
• Pregnant or lactating women;
• Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs；
• Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years；
• The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request；
• Patients with severe liver and kidney dysfunction (grade 4) should be excluded;
• Those who are allergic to any component of apafitini mesylate should be excluded;
• Mental disorders history, or psychotropic drug abuse history；
• According to the investigator's judgment, there are people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study;
• Surgery was performed within 4 weeks prior to the start of treatment, or patients with major trauma or fractures. Or there is an unhealed wound before treatment;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Interventions

apatinib

Central Study Contacts

Ning Li

CONTACT

13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 17, 2019

Record last verified: 2019-05