Advanced Gastric CancerPhase 2NCT03954756
Exploratory Clinical Study of Apatinib and PD-1 in Treating Advanced Gastric Cancer
A Phase 2 study testing Apatinib and PD1 in people with Advanced Gastric Cancer, run by Henan Cancer Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Apatinib and PD1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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。
Who cannot join
- 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);
- 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；
- Coagulation abnormalities （INR>1.5×ULN，APTT>1.5×ULN）,with bleeding tendency;
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- 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；
- Previous use of regorafenib is not an exclusion criterion；
- 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;
- 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;
- The patient has brain metastasis, meningeal metastasis;
- Active HBV infection and rejection of formal antiviral therapy;
- Active tuberculosis;
- Participants who have participated in any drug or medical device clinical trial within 1 month prior to the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer
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.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Apatinib and PD1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib and PD1Drug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Apatinib and PD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Measured: up to 2 year
Secondary outcomes (3)
Objective response rate
Defined as the proportion of patients with a documented complete response, and partial response (CR
+ PR
Measured: up to 2 year
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
Measured: up to 2 year
Overall survival
From date of randomization until the date of death from any cause
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954756
- Sponsor's protocol ID
- APD-L0315
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 17 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of the Combination of Apatinib and PD1 in Treating Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT03954756
- Acronym / sponsor ID
- APD-L0315
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib and PD-1 | Experimental | Drug: Apatinib and PD1Every 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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);
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib and PD11. 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. | Drug | apatinib and PD-1 |
Primary outcome
Overall survival rate
Time frame: up to 2 year
3 secondary outcomes
Objective response rate
Time frame: up to 2 year
Disease control rate
Time frame: up to 2 year
Overall survival
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and PD1 in people with Advanced Gastric Cancer, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Li (13526501903, lining97@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: up to 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.