Metastatic Pancreatic CancerPhase 2NCT04101929
Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen
A Phase 2 study testing Apatinib, S-1 capsule and Irinotecan in people with Metastatic Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and S-1 (ApaIRIS) in treating Patients with metastatic pancreatic cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Apatinib, S-1 capsule and Irinotecan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent and willing to complete the study according to the protocol
- ECOG performance scale ≤ 2;
- Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- Treatment of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen
- Baseline blood routine and biochemical indexes meet the following criteria:
- Blood routine examination criteria must be met: (no blood transfusion within 14 days)
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- HB≥90g/L；
- ANC≥1.5×109/L；
- PLT≥80×109/L
- Biochemical tests are subject to the following criteria:
- BIL <1.25xULN ；
- ALT and AST<2.5ULN；
- Serum creatinine. Less than 1 times the upper limit of normal value, Endogenous creatinine clearance>50ml/min ( Cockcroft-Gault formula).
- The advanced pancreatic cancer pathology, with measurable lesions (spiral CT scan is more than 10 mm, according to the standard of RECIST 1.1);
- Life expectancy ≥ 12 weeks;
- Doctors believe that treatment can bring benefits to patients.
Who cannot join
- unwilling or unable to comply with the study protocol;
- Other or malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Allergy to apatinib, S-1 raw materials and/or their excipients;
- Received VEGFR inhibitors, such as sorafenib, chougny for treatment;
- Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg);
- Suffering from coronary artery disease above grade I, grade I arrhythmia (including corrected QT interval prolongation male > 450 ms, women > 470 MS) and grade I heart insufficiency; urine protein positive patients.
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- Renal insufficiency, patients with previous kidney disease, urine protein positive (urinary protein detection 2+ or above, or 24-hour urine protein quantitation > 1.0g);
- Has a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.)
- Pregnant or lactating women;
- Coagulant function abnormality (INR>1.5、APTT>1.5 ULN) with bleeding tendency; Those with bleeding tendency (such as active ulcerative lesions in the stomach, fecal occult blood (++), vaginal and/or hematemesis within 3 months, hemoptysis) or lesions close to the large vessel site;
- Patients with a deficiency of dihydropyrimidine dehydrogenase are known;
- Evidence of any severe or uncontrolled systemic disease (eg, unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, high blood pressure, severe arrhythmia, diabetes, massive active bleeding);
- Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- According to the investigator's judgment, there are other serious patients who are at risk to the patient's safety or affect the patient's accompanying disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Xian-Jun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Wen-Quan Wang, M.D., Ph.D., +86-21-6417-5590, wangwenquan@fudanpci.org
About this study
Official title: A Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Apatinib Combined With Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Albumin-bound Paclitaxel Plus Gemcitabine Regimen
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and S-1 (ApaIRIS) in treating Patients with metastatic pancreatic cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen
Read the detailed description
While AG (albumin-bound paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after AG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received apatinib, irinotecan and S-1. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.
The efficacy and safety data will be assessed through PFS, OS, ORR and adverse effects as graded by CTC-AE 5.0.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Apatinib, S-1 capsule, Irinotecan
- Keywords
- metastatic pancreatic cancer, pancreatic adenocarcinoma, apatinib, S-1, irinotecan
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Patients receive Apatinib 250mg po qd , Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
S-1 capsuleDrug
Patients receive S-1 capsule According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle, Treatment repeats until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
IrinotecanDrug
Patients receive Irinotecan According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Continuous chemotherapy until the criteria for discontinuation of the drug are met (eg, progression of the disease, intolerance of adverse reactions, or withdrawal of informed consent by the patient).
Because the toxicity of apatinib or irinotecan or tigeol in the chemotherapy regimen meets the withdrawal criteria, the drug can be discontinued alone and the exact duration of the trial treatment recorded.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Apatinib + S-1+ Irinotecan | Experimental | Apatinib: 250mg po qd； S-1 capsule: According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle; Irinotecan: According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Receives: Drug: Apatinib; Drug: S-1 capsule; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Overall Survival
To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).
Measured: through study completion, an average of 1 year
Incidence of Adverse Events
Adverse events of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS).
Measured: through study completion, an average of 1 year
Overall Response Rate
To evaluate the overall response rate of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xian-Jun Yu, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101929
- Sponsor's protocol ID
- CSPAC-25
- Status last verified
- Nov 2019
- First submitted
- 22 Sep 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Apatinib Combined With Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Albumin-bound Paclitaxel Plus Gemcitabine Regimen
- ClinicalTrials.gov ID
- NCT04101929
- Acronym / sponsor ID
- CSPAC-25
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- metastatic pancreatic cancer, pancreatic adenocarcinoma, apatinib, S-1, irinotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Sep 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.
This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of apatinib combined with irinotecan and S-1 (ApaIRIS) in treating Patients with metastatic pancreatic cancer after chemotherapy with albumin-bound paclitaxel plus gemcitabine regimen
Detailed description
While AG (albumin-bound paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after AG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received apatinib, irinotecan and S-1. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic.
The efficacy and safety data will be assessed through PFS, OS, ORR and adverse effects as graded by CTC-AE 5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Apatinib + S-1+ Irinotecan | Experimental | Drug: Apatinib, Drug: S-1 capsule, Drug: IrinotecanApatinib: 250mg po qd； S-1 capsule: According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle; Irinotecan: According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent and willing to complete the study according to the protocol
- ECOG performance scale ≤ 2;
- Diagnosed as pancreatic adenocarcinoma by histology and cytology;
- Treatment of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen
- Baseline blood routine and biochemical indexes meet the following criteria:
Key exclusion criteria (14 listed)
- unwilling or unable to comply with the study protocol;
- Other or malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- Allergy to apatinib, S-1 raw materials and/or their excipients;
- Received VEGFR inhibitors, such as sorafenib, chougny for treatment;
- Have high blood pressure and antihypertensive drug treatment can not drop to normal range(systolic pressure >140 mmHg, diastolic blood pressure 90>mmHg);
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 |
|---|---|---|
| ApatinibPatients receive Apatinib 250mg po qd , Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic. | Drug | Experimental: Apatinib + S-1+ Irinotecan |
| S-1 capsulePatients receive S-1 capsule According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle, Treatment repeats until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic. | Drug | Experimental: Apatinib + S-1+ Irinotecan |
| IrinotecanPatients receive Irinotecan According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Continuous chemotherapy until the criteria for discontinuation of the drug are met (eg, progression of the disease, intolerance of adverse reactions, or withdrawal of informed consent by the patient). Because the toxicity of apatinib or irinotecan or tigeol in the chemotherapy regimen meets the withdrawal criteria, the drug can be discontinued alone and the exact duration of the trial treatment recorded. | Drug | Experimental: Apatinib + S-1+ Irinotecan |
Primary outcome
Progression Free Survival
Time frame: through study completion, an average of 1 year
To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with AG (albumin and gemcitabine) regimen after treatment with Apatinib combined with Irinotecan and S-1 (ApaIRIS)
3 secondary outcomes
Overall Survival
Time frame: through study completion, an average of 1 year
Incidence of Adverse Events
Time frame: through study completion, an average of 1 year
Overall Response Rate
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Xian-Jun Yu study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib, S-1 capsule and Irinotecan in people with Metastatic Pancreatic Cancer, run by Fudan University at 1 site in China.
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 16 inclusion and 14 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xian-Jun Yu (+86 21 6417559, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: through study completion, an average of 1 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 5 Nov 2019.