Clinical trial · Interventional
Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer
NCT03662035CI-TRIAL-00034954ASPCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study was to determine the efficacy and safety of apatinib combined with S-1 on advanced pancreatic cancer patients after failure of first-line chemotherapy.
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 |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm
- description
- Apatinib and S-1 Patients will be offered with Apatinib (500mg/d) and S-1 (60mg/d for BSA\<1.25m2, 80mg/d for 1.25\<BSA\<1.5m2, and 100mg for BSA \>1.5m2) until their disease have progressed.
- interventionNames
- Drug: Apatinib
- Drug: S-1
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- one year.
- description
- Progression-free survival is defined as the time from registration to the earlier of death or disease progression.
Secondary outcomes (4)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion criteria:
* 18-70 years old;
* ECOG score: 0-2;
* Have confirmed metastatic or locally advanced unresectable pancreatic cancer;
* At least one measurable lesion according to the RECIST1.1 standard;
* First-line chemotherapy drugs do not include S-1 or fluorouracil drugs;
* Main organ functions meet the following standards:
* Baseline blood routine (the inspection standard should meet the requirements of no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulant correction) :
* Hemoglobin\>80g/L
* The absolute neutrophil count (ANC) 1.5 x 109 / L;
* Blood platelet (PLT)\> 90 x 109 / L;
* Baseline biochemical test shall meet the following standards:
* T BIL \< 1.5\*ULN.
* A LT and AST\<2.5\*ULN, and in patients with liver metastasis \< 5\*ULN;
* Cr≤1.5\*ULN.
* Albumin is greater than or equal to 30g/L;
* Women of child-bearing age must already have access to reliable contraception. Pregnancy tests (serum or urine) were performed within 7 days prior to enrollment and the results were negative, and a reliable method of contraception was preferred 8 weeks after the trial period and the last drug administration;
* Subjects will voluntarily join the study and sign the informed consent.
Exclusion criteria:
* Clearly allergic to apatinib, S-1 or their excipients;
* There are various factors affecting oral drugs (including dysphagia, chronic diarrhea, intestinal obstruction, etc.);
* Serious heart diseases in the last six months, including :
* angina;
* myocardial infarction;
* heart failure;
* interphase of QTc \>450ms;
* any other heart diseases that were judged as unsuitable for the study;
* Combined with uncontrollable hypertension after drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg);
* Complicated with other serious medical diseases, including cerebrovascular disease, uncontrolled infection, active peptic ulcer, intestinal obstruction, etc.;
* Metastasis of tumor central nervous system;
* Women during pregnancy and lactation;
* The patient has been diagnosed with other tumors in the past five years, except for the following situations: B. Cured basal cell carcinoma of the skin and cured orthotopic carcinoma of the cervix;
* The time from the last chemotherapy is shorter than 4 weeks or 5 half-life (the time taken is older), and the time from the last radiotherapy is shorter than 4 weeks;
* Use the experimental drug within 28 days before enrollment;
* Patients with grade 2 or above toxicity caused by the use of anti-tumor drugs before enrollment;
* Have mental disorders or a history of substance abuse;
* Other circumstances that the investigator deems inappropriate to participate in the study;References
Publications (0)
Data not yet available
No reference posted for this study.