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

Phase 2

• Conditions: Pancreatic Cancer; Chemotherapy Effect
• Interventions: Drug: raltitrexed for injection; Drug: nab-paclitaxel

• Registration Number: NCT04581876
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-06-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-03
• Last Update Submitted: 2020-10-03
• Study First Posted: 2020-10-09
• Last Update Posted: 2020-10-09
• Primary Completion: 2022-09-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
raltitrexed for injection + nab-paclitaxel	raltitrexed for injection	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.
raltitrexed for injection + nab-paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
objective response rate	up to 36 months	To evaluate the objective response rate of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
progression free survival	up to 36 months	To evaluate progression free survival of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.

Secondary Outcome Measures

Name	Time	Method
overall survival	up to 36 months	To evaluate the overall survival of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
adverse events	up to 36 months	To evaluate the adverse events of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.

Trial Locations

Locations (1)

Fudan University; 🇨🇳 Shanghai, Shanghai, China