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Status unknownNCT03954756Updated May 17, 2019

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

A Phase 2 interventional study of Apatinib and PD1 in Advanced Gastric Cancer, sponsored by Henan Cancer Hospital. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-17.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Advanced Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 35 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    apatinib and PD-1

    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

  • DrugApatinib and PD1

    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.

06

What researchers measure

Primary outcomes

  1. Overall survival rate

    Time frame: up to 2 year

Secondary outcomes

  1. Objective response rate

    Defined as the proportion of patients with a documented complete response, and partial response (CR + PR

    Time frame: up to 2 year

  2. 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

    Time frame: up to 2 year

  3. Overall survival

    From date of randomization until the date of death from any cause

    Time frame: up to 2 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03954756
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Jun 1, 2019 (estimated)
Primary completion
Jun 1, 2021 (estimated)
Completion
Jun 1, 2021 (estimated)
Last update
May 17, 2019

Study contacts

Ning Li
Contact
lining97@126.com
13526501903

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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