The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    120
  • sponsor
    Fudan University
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Updated on 25 January 2021
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paclitaxel
cancer chemotherapy

Summary

The present study is intended to investigate the safety and efficacy of the patients with confirmed advanced pancreatic cancer after treating with the combination of raltitrexed for injection and nab-paclitaxel.

Description

Conditions: Advanced pancreatic cancer subjects which were prospectively to receive first-line chemotherapy.

Keywords: Advanced pancreatic cancer; paclitaxel liposome; S-1 Interventions: Drug: paclitaxel liposome; Drug:S-1 Phase: Phase IV Study Type: Interventional

Study Design:

Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Primary Purpose: Treatment MedlinePlus related topics: Cancer, Pancreatic Cancer Drug Information available for: paclitaxel liposomepaclitaxel liposome for injection S-1Tegafur, Gimeracil and Oteracil Potassium Capsules

Primary Outcome Measures:

To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.

Secondary Outcome Measures:

To evaluate the Overall Response Rateoverall survivaldisease control rateQuality of Lifeadverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Pancreatic disorder, Pancreatic Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Pancreatic Disorders, Chemotherapy Effect, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Nab-paclitaxel, raltitrexed for injection
Clinical Study IdentifierNCT04581876
SponsorFudan University
Last Modified on25 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Signed informed content obtained prior to treatment
The patients were confirmed as advanced pancreatic cancer by histopathology or cytology
At least one measurable objective lesion was identified based on the RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
The expected survival after surgery 3 months
Subjects had good compliance, were able to undergo treatment and follow-up, and voluntarily followed the relevant regulations of this study
No contraindications to the use of raltitrexed for injection and nab-paclitaxel
Age 18 years and 75 years
Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 7 days before the start of chemotherapy, during the monthly treatment interval and after the last treatment
Women must be non-lactating

Exclusion Criteria

The target disease has cerebral metastasis
The medical history and complications, which may affect patients' ability to participate in the study and their safety during the study, or interfere with explanation of the study results, for example: severe cardiovascular and cerebrovascular diseases, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc
Dementia, altered mental state, or any mental illness that prevents understanding or informed consent or questionnaires
History of allergy or hypersensitivity to any therapeutic ingredient
Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of admission, excepted cured basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery
Subjects with peripheral neuropathy 2 according to CTCAE version 5.0
Physical examination or laboratory examination results are abnormal
Hematological dysfunction is defined as: i) absolute neutrophil (ANC) count <1.5 109 / L; ii) platelet (PLT) count: <100 109 / L; iii) hemoglobin (Hb) level<90g / L
Hepatic abnormalities are defined as: i) total bilirubin (TBil) levels: >1.5 times the upper limit of normal (ULN); ii) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels >2.5 times the ULN >5 times ULN if liver metastases are present
Definition of renal dysfunction: serum creatinine >1.5 times ULN, or calculated creatinine clearance <50ml / min
Definition of abnormal blood coagulation function: International Normalized Ratio (INR) >1.5 times of ULN, and prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5 times of ULN, unless the subject is receiving anti-antibodies Coagulation treatment
Hepatitis B surface antigen positive (HBsAg), and subjects with peripheral blood hepatitis B virus DNA (HBV-DNA) titer 1103 copies / L; if HBsAg is positive, and peripheral blood HBV-DNA <1103 copy number / L, if the researcher believes that the subject's chronic hepatitis B is in a stable phase and does not increase the risk of the subject, the subject is eligible for selection
Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive
Patients who need to combine other anti-tumor drugs
Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period
Other conditions that researchers not think to be suitable for enrollment
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