Pancreatic CancerPhase 2NCT04581876
The Safety and Efficacy of the Combination of Raltitrexed for Injection and Nab-Paclitaxel in Advanced Pancreatic Cancer
A Phase 2 study testing raltitrexed for injection and nab-paclitaxel in people with Pancreatic Cancer and Chemotherapy Effect, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Chemotherapy Effect
- What is being tested?
- raltitrexed for injection and nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
- Other conditions that researchers not think to be suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality, 200032
Wen-Quan Wang, +86 21 64175590, wangwenquan@fudanpci.org
Xian-Jun Yu
About this study
Official title: A Single-arm, Prospective Study to Evaluate the Safety and Efficacy and of the Combination of Raltitrexed for Injection and Nab-Paclitaxel as Second-line Therapy in Treating Patients With Advanced Pancreatic Cancer
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.
Read the 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
- Being tested
- raltitrexed for injection, nab-paclitaxel
- Keywords
- Advanced pancreatic cancer, raltitrexed for injection, nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raltitrexed for injectionDrug
Also called raltitrexed
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-paclitaxelDrug
Also called albumin-bound 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: raltitrexed for injection; Drug: nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 36 months
Secondary outcomes (2)
overall survival
To evaluate the overall survival of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
Measured: up to 36 months
adverse events
To evaluate the adverse events of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start1 Nov 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xian-Jun Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581876
- Sponsor's protocol ID
- CSPAC-24
- Status last verified
- Oct 2020
- First submitted
- 30 Jun 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Study to Evaluate the Safety and Efficacy and of the Combination of Raltitrexed for Injection and Nab-Paclitaxel as Second-line Therapy in Treating Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04581876
- Acronym / sponsor ID
- CSPAC-24
- Conditions
- Pancreatic Cancer, Chemotherapy Effect
- Keywords
- Advanced pancreatic cancer, raltitrexed for injection, nab-paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| raltitrexed for injection + nab-paclitaxel | Experimental | Drug: raltitrexed for injection, Drug: nab-paclitaxelPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| raltitrexed for injectionAlso: raltitrexedPatients 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. | Drug | raltitrexed for injection + nab-paclitaxel |
| nab-paclitaxelAlso: albumin-bound paclitaxelPatients 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. | Drug | raltitrexed for injection + nab-paclitaxel |
Primary outcome
objective response rate
Time frame: 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
Time frame: 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.
2 secondary outcomes
overall survival
Time frame: up to 36 months
adverse events
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xian-Jun Yu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing raltitrexed for injection and nab-paclitaxel in people with Pancreatic Cancer and Chemotherapy Effect, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xian-Jun Yu, MD, PhD (+86 21 64175590, wangwenquan@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.