Clinical trial · Interventional
Apatinib, Irinotecan and S-1 (ApaIRIS) in Treating Patients With Metastatic Pancreatic Cancer After AG Regimen
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
| S-1 capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Apatinib + S-1+ Irinotecan
- description
- 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.
- interventionNames
- Drug: Apatinib
- Drug: S-1 capsule
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- through study completion, an average of 1 year
- description
- 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)
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* 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:
1. Blood routine examination criteria must be met: (no blood transfusion within 14 days)
1. HB≥90g/L;
2. ANC≥1.5×109/L;
3. PLT≥80×109/L
2. Biochemical tests are subject to the following criteria:
1. BIL \<1.25xULN ;
2. ALT and AST\<2.5ULN;
3. 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.
Exclusion Criteria:
* 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.
* 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.References
Publications (0)
Data not yet available