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Pancreatic CancerPhase 2NCT05168527

The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients

A Phase 2 study testing Fruquintinib,Albumin Paclitaxel,Gemcitabine in people with Pancreatic Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Fruquintinib,Albumin Paclitaxel,Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
3 Sep 2021to 31 May 2024
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years old;
  • Pancreatic cancer was confirmed by pathology or cytology;
  • Liver-metastatic confirmed by pathology or clinical imaging;
  • Newly treated patients who have not received any systemic treatment for pancreatic cancer are allowed to enter the group for patients who have previously used fluorouracils (excluding gemcitabine and or taxanes) as adjuvant treatments for recurrence;
  • ECOG score of preoperative physical condition was 0-1;
  • Expected survival time ≥3months;
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  • There is at least one measurable lesion under CT evaluation according to the RECIST 1.1 standard,;
  • The patient has sufficient hematological function (not receiving blood, platelet transfusion or growth factor supportive therapy within 14 days before the start of the study treatment), determined according to the following laboratory test values:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelets ≥ 100 × 109/L;
  • Hemoglobin ≥ 9.0 g/dL;
  • The patient has sufficient liver and kidney function, which is determined according to the following laboratory test values:
  • Serum creatinine ≤ 1.5 × ULN;
  • If serum creatinine>1.5 × ULN, creatinine clearance rate ≥50ml/min;
  • Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) in non-liver metastatic lesions ≤ 2.5 × ULN, and AST and ALT ≤ 5.0 × ULN in liver metastatic lesions;
  • Serum albumin ≥ 2.5 g/dL;
  • Total bilirubin ≤1.5 × ULN;
  • Men, women of childbearing age (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take it during treatment and at least six months after the last study drug is taken by the investigator. Effective contraceptive measures;
  • Able to understand and voluntarily sign a written informed consent form and voluntarily complete the research procedures and follow-up inspections. The informed consent form must be signed before the implementation of any research procedures specified by the trial

Who cannot join

  • Received chemotherapy within 14 days before entering the study.
  • Received VEGFR signaling pathway therapy or other anti-cancer therapy within 14 days before enrollment.
  • Received radiotherapy within 14 days before enrollment, and received chest radiotherapy within 28 days before enrollment.
  • Active central nervous system involvement is known.
  • Oral anticoagulant is being used, or an inhibitor or inducer of potent cytochrome oxidase 3A4 (CYP3A4) is being used (see Appendix 1 for details). Allow the use of subcutaneous anticoagulants.
  • Patients who have participated in clinical trials of reagents or new drugs under investigation within 28 days before the first treatment administration (phase I-IV clinical trials).
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  • Adverse reactions caused by previous anti-tumor treatments did not recover to grade 1 or below (hair loss and peripheral neuropathy did not recover to grade 2 or below).
  • Active infection or unexplained fever> 38.5°C occurred within 2 weeks before the first administration (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor).
  • Various chronic active infections, such as hepatitis B virus (evidence of hepatitis activity such as HBV-DNA ≥104 copies/ml or 2000IU/ml), hepatitis C and HIV.
  • Patients with elevated serum troponin T or I (above the normal limit specified by the research center).
  • Pregnant or lactating (lactating) women, where pregnancy is defined as the state of a woman after conception until the end of pregnancy, and the result of a serum β-human chorionic gonadotropin (β-hCG) laboratory test is confirmed to be positive.
  • Any of the following cardiac standards: the average QTcF calculated according to Fridericia's formula during the rest period of the screening period [QTcF = QT/(RR1/3), RR is the standardized heart rate value, obtained by dividing 60 by the heart rate]: male> 450 milliseconds , Female> 470 milliseconds; any clinically important abnormalities in the rhythm, conduction or morphology of the resting electrocardiogram (ECG) (for example, complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome.
  • According to the investigator's judgment, patients who have not fully recovered after surgery, patients whose wounds are in an active healing stage, patients who underwent major surgery within 28 days before the start of the study, and patients who underwent minor surgery within 14 days before the start of the study.
  • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines , Uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, heart block above II, congestive heart failure (CHF), myocardial infarction in the past 6 months , Unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung disease (history of interstitial pneumonia, obstructive lung disease and symptomatic bronchospasm).
  • Any other situation that the researcher considers inappropriate to participate in clinical research.

Trial locations and contacts

1 site in 1 country.

Xianjun MD Yu, PhD contact

+86-18017317266

yuxianjun@fudanpci.org

Si Shi contact

+86-18121299331

shisi@fudanpci.org

China1 site, 1 recruiting

  • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

    Shanghai, Shanghai Municipality, 200032

    XianJun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org

    Xianjun Yu, M.D., Ph.D.

    Recruiting

Other trials in China

About this study

Official title: An Open Single-center Phase II Clinical Study of Fruquintinib Combined With Chemotherapy in Patients With Liver Metastases From Pancreatic Cancer

The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients.

Read the detailed description

Pancreatic cancer is the most deadly malignant tumor commonly found in the digestive system and is known as the king of cancer. According to the global cancer statistics released in 2018, there are about 458,900 new cases of pancreatic cancer worldwide each year, and the number of deaths due to pancreatic cancer each year is about 432,200. The data of pancreatic cancer collected by the National Cancer Center of China in 2019 showed that the incidence rate was 6.92 per 100,000, and new cases accounted for about 4.31% of all malignant tumors, ranking 10th; the case fatality rate was 6.16 per 100,000, with deaths every year It accounts for about 3.78% of all malignant tumors, ranking 7th. Compared with urban areas and rural areas, the morbidity and mortality have increased compared with previous years. The incidence of pancreatic cancer has been increasing year by year worldwide, and it is expected that by 2030, it will surpass colorectal cancer and breast cancer to become the second cancer-fatal tumor. Pancreatic cancer is extremely malignant, with a 5-year survival rate of only 9%, and its case fatality rate is basically equal to the incidence rate. The case fatality rate of pancreatic cancer may continue to rise, which will seriously threaten and affect human health.

The specific etiology and pathogenesis of pancreatic cancer are currently unclear, the early clinical manifestations are not obvious, the rapid development, the extremely high degree of malignancy, and the poor prognosis, all of which lead to the refractory and high mortality of pancreatic cancer. It is precisely because the early symptoms are not typical and the clinical signs are not obvious, most patients are already in the locally advanced stage or have distant metastases when they are diagnosed.In this case, the chance of surgical treatment is low and the effect is not ideal. 80% of pancreatic cancer patients are already in the inoperable advanced stage at the time of diagnosis, and more than 50% of them have found metastases at the time of diagnosis, and have lost the chance of radical surgery. The most common distant metastasis site is the liver. At present, for patients with liver metastases from pancreatic cancer, the standard treatment regimen in domestic and foreign guidelines is palliative treatment based on chemotherapy.

According to the latest updated treatment guidelines for metastatic pancreatic cancer by the American Society of Clinical Oncology (ASCO), the first-line chemotherapy regimen should be selected based on the patient's physical status. For patients with good physical status, a combination regimen may be considered, and patients with poor physical status should choose single-agent chemotherapy. Or the best supportive treatment. For those with good physical status, FOLFIRINOX, gemcitabine and paclitaxel are recommended; for patients with poor physical status, single-agent gemcitabine can be used. If tolerable, they can be combined with albumin paclitaxel or calciner under the guidance of an experienced oncologist. Petabine or erlotinib. Overall, the median OS of first-line chemotherapy did not exceed 12 months, and the median OS of second-line chemotherapy ranged from 3.3 to 9.9 months. Therefore, the overall treatment effect of pancreatic cancer was poor, and the median survival was only 6 months. For 8 months, the effect was not good. All major guidelines recommend the development of multi-center clinical studies to prolong patient survival and discover new effective drugs. In summary, actively exploring new comprehensive treatment strategies, breaking through treatment options for advanced pancreatic cancer, improving the survival time of patients with liver metastases of pancreatic cancer, and exploring the biological characteristics of liver metastases of pancreatic cancer are important clinical issues that urgently need to be resolved.

Being tested
Fruquintinib,Albumin Paclitaxel,Gemcitabine
Keywords
Pancreatic Cancer, Safety and Effectiveness, TKI, Chemotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fruquintinib,Albumin Paclitaxel,GemcitabineDrug

    The study will mainly explore the safety and tolerability of fixed-dose level of Fruquintinib (4 mg, continuous medication for 3 weeks and withdrawal for 1 week) combined with fixed-dose level of albumin paclitaxel and gemcitabine. The fixed dose of Fruquintinib is 4 mg, with a treatment cycle every 28 days. A 28-day observation window was used to explore the side effects of fruquintinib in the combined treatment of pancreatic cancer patients with liver metastases. Evaluable patients will be assessed for DLT within 28 days after the first administration of the study drug. The 24 patients enrolled in the follow-up group will mainly evaluate the initial efficacy of furquintinib combined with albumin paclitaxel and gemcitabine as the first-line standard treatment for patients with metastatic pancreatic cancer.

Study groups in NCT05168527
Study groupRoleWhat they receive
experimental groupExperimentalThis is an opened single-arm phase 2 study， the study drug includes Fruquintinib combine with Paclitaxel Injection and Gemcitabine.
Receives: Drug: Fruquintinib,Albumin Paclitaxel,Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: through study completion, an average of 1 year

Secondary outcomes (4)

  1. PFS

    Progression-free survival

    Measured: through study completion, an average of 1 year

  2. DCR

    Disease control Rate

    Measured: through study completion, an average of 1 year

  3. OS

    Overall Survival

    Measured: through study completion, an average of 1 year

  4. DOR

    Duration of Remission

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start3 Sep 2021
  3. Primary completion2 Mar 2024 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168527
Sponsor's protocol ID
HMPL-013-NG
Status last verified
Dec 2021
First submitted
8 Dec 2021
Last updated
14 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alvarez R, Musteanu M, Garcia-Garcia E, Lopez-Casas PP, Megias D, Guerra C, Munoz M, Quijano Y, Cubillo A, Rodriguez-Pascual J, Plaza C, de Vicente E, Prados S, Tabernero S, Barbacid M, Lopez-Rios F, Hidalgo M. Stromal disrupting effects of nab-paclitaxel in pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):926-33. doi: 10.1038/bjc.2013.415. Epub 2013 Aug 1.

    PubMed 23907428

  • Sankaranarayanan R. Cancer survival in Africa, Asia, the Caribbean and Central America. Introduction. IARC Sci Publ. 2011;(162):1-5.

    PubMed 21675400

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.

    PubMed 9196156

  • Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

    PubMed 26802160

  • Chu GC, Kimmelman AC, Hezel AF, DePinho RA. Stromal biology of pancreatic cancer. J Cell Biochem. 2007 Jul 1;101(4):887-907. doi: 10.1002/jcb.21209.

    PubMed 17266048

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • da Rocha Lino A, Abrahao CM, Brandao RM, Gomes JR, Ferrian AM, Machado MC, Buzaid AC, Maluf FC, Peixoto RD. Role of gemcitabine as second-line therapy after progression on FOLFIRINOX in advanced pancreatic cancer: a retrospective analysis. J Gastrointest Oncol. 2015 Oct;6(5):511-5. doi: 10.3978/j.issn.2078-6891.2015.041.

    PubMed 26487945

  • Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

    PubMed 26372701

  • Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

    PubMed 19097774

  • Eltawil KM, Renfrew PD, Molinari M. Meta-analysis of phase III randomized trials of molecular targeted therapies for advanced pancreatic cancer. HPB (Oxford). 2012 Apr;14(4):260-8. doi: 10.1111/j.1477-2574.2012.00441.x. Epub 2012 Feb 26.

    PubMed 22404265

  • Gilabert M, Chanez B, Rho YS, Giovanini M, Turrini O, Batist G, Kavan P, Raoul JL. Evaluation of gemcitabine efficacy after the FOLFIRINOX regimen in patients with advanced pancreatic adenocarcinoma. Medicine (Baltimore). 2017 Apr;96(16):e6544. doi: 10.1097/MD.0000000000006544.

    PubMed 28422841

  • Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.

    PubMed 27621395

  • Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.

    PubMed 10647931

  • Hidalgo M. Pancreatic cancer. N Engl J Med. 2010 Apr 29;362(17):1605-17. doi: 10.1056/NEJMra0901557. No abstract available.

    PubMed 20427809

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib,Albumin Paclitaxel,Gemcitabine in people with Pancreatic Cancer, 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 19 inclusion and 15 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 14 Jan 2022. 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 Xianjun MD Yu, PhD (+86-18017317266, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168527, which also lists 42 linked publications.

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 14 Jan 2022.

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