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

NCT ID: NCT04581876

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-03-01

Brief 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.

Detailed 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 liposome：paclitaxel liposome for injection S-1：Tegafur, 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 Rate、overall survival、disease control rate、Quality of Life、adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.

Conditions

Pancreatic Cancer; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

raltitrexed for injection + nab-paclitaxel

Patients receive raltitrexed 2mg/m2 (iv, 15min) and nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

Group Type: EXPERIMENTAL

raltitrexed for injection

Intervention Type: DRUG

Patients receive raltitrexed 2mg/m2 (iv, 15min) on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

nab-paclitaxel

Intervention Type: DRUG

Patients receive nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

Interventions

raltitrexed for injection

Patients receive raltitrexed 2mg/m2 (iv, 15min) on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

Intervention Type: DRUG

nab-paclitaxel

Patients receive nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.

Intervention Type: DRUG

Other Intervention Names

raltitrexed; albumin-bound paclitaxel

Eligibility Criteria

Inclusion Criteria

1. Signed informed content obtained prior to treatment;

2. The patients were confirmed as advanced pancreatic cancer by histopathology or cytology;

3. At least one measurable objective lesion was identified based on the RECIST 1.1 criteria;

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

5. The expected survival after surgery ≥3 months;

6. Subjects had good compliance, were able to undergo treatment and follow-up, and voluntarily followed the relevant regulations of this study;

7. No contraindications to the use of raltitrexed for injection and nab-paclitaxel;

8. Age ≥18 years and ≤75 years;

9. 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;

10. Women must be non-lactating.

Exclusion Criteria

1. The target disease has cerebral metastasis;

2. 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.;

3. Dementia, altered mental state, or any mental illness that prevents understanding or informed consent or questionnaires;

4. History of allergy or hypersensitivity to any therapeutic ingredient;

5. 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;

6. Subjects with peripheral neuropathy ≥2 according to CTCAE version 5.0;

7. Physical examination or laboratory examination results are abnormal;

1. 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;

2. 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;

3. Definition of renal dysfunction: serum creatinine >1.5 times ULN, or calculated creatinine clearance <50ml / min;

4. 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.

8. Hepatitis B surface antigen positive (HBsAg), and subjects with peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥1×103 copies / L; if HBsAg is positive, and peripheral blood HBV-DNA <1×103 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;

9. Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive;

10. Patients who need to combine other anti-tumor drugs;

11. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.

12. Other conditions that researchers not think to be suitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xian-Jun Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xian-Jun Yu, MD, PhD

Role: CONTACT

wangwenquan@fudanpci.org

+86 21 64175590

Facility Contacts

Wen-Quan Wang

Role: primary

wangwenquan@fudanpci.org

+86 21 64175590

Other Identifiers

CSPAC-24

Identifier Type: -

Identifier Source: org_study_id