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

NCT04581876 | Unknown Phase 2

• 1 other identifier: CSPAC-24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Chemotherapy Effect

Keywords

Advanced pancreatic cancer; raltitrexed for injection; nab-paclitaxel

Outcome Measures

Primary Outcomes (2)

• objective response rate

  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.

  up to 36 months

• progression free survival

  To evaluate progression free survival of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.

  up to 36 months

Secondary Outcomes (2)

• overall survival

  up to 36 months

• adverse events

  up to 36 months

Study Arms (1)

raltitrexed for injection + nab-paclitaxel

EXPERIMENTAL

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.

Drug: raltitrexed for injection; Drug: nab-paclitaxel

Interventions

raltitrexed for injection 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.

Also known as: raltitrexed

raltitrexed for injection + nab-paclitaxel

nab-paclitaxel 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.

Also known as: albumin-bound paclitaxel

raltitrexed for injection + nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ≥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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

raltitrexed; Injections; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Xian-Jun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian-Jun Yu, MD, PhD

CONTACT

+86 21 64175590; wangwenquan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: October 9, 2020
• Study Start: November 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)