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

Advanced Gastric Cancer Clinical Trial

Official title:

Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03954756
• Other study ID #: APD-L0315
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: Henan Cancer Hospital
• Contact: Ning Li
• Phone: 13526501903
• Email: lining97[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients will received apatinib orally every day and PD-1 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

2. To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed advanced Gastric Cancer.

3. 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.

4. Aged 18-70 years old, both genders.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

6. Life expectancy of at least 3 months.

7. 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.

8. 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;

9. 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?

Exclusion Criteria:

1. 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;

2. Diabetes blood sugar control is poor;

3. Acute phase of cerebral infarction, or recovery period <2 months;

4. 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);

5. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion;

6. Coagulation abnormalities (INR>1.5×ULN,APTT>1.5×ULN),with bleeding tendency;

7. Urine protein = ++ or confirmed 24 hour urine protein quantitation > 1.0 g;

8. Pregnant or lactating women;

9. Within 2 weeks after treatment with cytotoxic drugs and radiotherapy;Has taken two or more oral targeted drugs;

10. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years;

11. 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;

12. Patients with severe liver and kidney dysfunction (grade 4) should be excluded;

13. Those who are allergic to any component of apafitini mesylate should be excluded;

14. Mental disorders history, or psychotropic drug abuse history;

15. Previous use of regorafenib is not an exclusion criterion;

16. 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;

17. 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;

18. Patients with severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, or grade III or above (CCS standard) angina, or a history of myocardial infarction within 6 months prior to treatment, or an arrhythmia requiring medication;

19. The patient has brain metastasis, meningeal metastasis;

20. Active HBV infection and rejection of formal antiviral therapy;

21. Active tuberculosis;

22. Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib and PD1
Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		up to 2 year
Secondary	Objective response rate	Defined as the proportion of patients with a documented complete response, and partial response (CR; + PR	up to 2 year
Secondary	Disease control rate	The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason	up to 2 year
Secondary	Overall survival	From date of randomization until the date of death from any cause	up to 2 year