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Nasopharyngeal CarcinomaPhase 3NCT05780294

A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet Whole-course Management Assisted by PFLL Chemotherapy in the Treatment of Stage IV, Recurrent or Metastatic NPC

A Phase 3 study testing 5-fu, Lobaplatin and leucogen in people with Nasopharyngeal Carcinoma and Leucogen, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Toxic and side effects during and after chemoradiotherapy for nasopharyngeal carcinoma seriously affect patients' treatment compliance and long-term quality of life. Active and effective prediction, prevention and management of toxic and side effects is an important element to improve the prognosis of patients. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Nasopharyngeal Carcinoma, Leucogen, Chemotherapy
What is being tested?
5-fu, Lobaplatin and leucogen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
1 siteChina
Study dates
1 Apr 2023to 1 Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • ≥18 years old and ≤60 years old；
  • Pathological diagnosis of stage IV, recurrent or distant metastatic nasopharyngeal carcinoma；
  • Patients with stage IV, metastatic (including primary and secondary) or recurrent nasopharyngeal carcinoma who are not suitable for local treatment, local treatment mainly refers to measures related to anti-tumor therapy, including surgery, radiofrequency ablation, transhepatic artery chemoembolization (TACE), radiotherapy (excluding bone metastases, local moderate amount of radiation therapy for symptom relief without affecting hematological indicators)；
  • Karnofsky functional status score should be at least 70 points (the decline of functional status score caused by tumor should be appropriately relaxed after the judgment of the researcher, and the minimum score should be no less than 50 points. );
  • At least 1 measurable lesion according to RECIST1.1 assessment criteria, measurable lesion should not have received local treatment such as radiotherapy;
  • Expected survival ≥3 months;
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  • The function of vital organs meets the following requirements (not allowed within 14 days before screening . May use any blood components, cell growth factors, leukoplast, platelets Drugs, anemia correction drugs) :
  • Neutrophil absolute count (ANC) ≥1.5×109/L
  • Platelet ≥100×109/L;
  • Hemoglobin ≥8.0g/ dL (note: Hemoglobin ≥8.0g/ dL can be achieved through blood transfusion or other intervention);
  • Serum albumin ≥2.8g/dL;
  • Bilirubin ≤ 1.5x ULN, ALT and AST≤ 1.5x ULN; ALT and AST≤ 5x ULN if liver metastasis was present;
  • creatinine clearance ≥50mL/min
  • Women of non-surgical sterilization or reproductive age and sexually active men enrolled in the study are required to use a medically effective form of contraception (such as an intrauterine device [IUD], birth control pills or condoms) for the duration of the study treatment and for at least 3 months after the last use of Tamfu and for at least 6 months after the last use of chemotherapy; The serum or urine HCG test of female patients of reproductive age who were not undergoing surgical sterilization must be negative within 7 days prior to study enrollment. And must be non lactation period;
  • Informed consent has been signed. -

Who cannot join

  • Have a history of allergy to 5-FU, cisplatin and leucogen;
  • Received elevated blood therapy 14 days prior to screening (including cytokines, leuk-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc.)
  • Major surgery other than nasopharyngeal cancer was diagnosed within 28 days prior to randomization or major surgery was expected during the study period;
  • The subject has any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); Subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; Subjects with asthma requiring medical intervention with bronchodilators were excluded);
  • Subject is taking immunosuppressants, or systemic, or absorbable sites Hormone therapy to achieve immunosuppression (dose >10mg/ day prednisone or Other equally effective hormones) and continued to be used within 2 weeks prior to enrollment.
  • The subject has previous or co-existing malignancies (except those that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid);
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  • Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: # HEART failure of NYHA grade 2 or above # unstable angina pectoris # myocardial infarction within 1 year # clinically significant ventricular arrhythmias or ventricular arrhythmias requiring treatment or intervention;
  • Subjects have active infection or have unexplained fever >38.5 degrees during screening but before the first dose (the investigator judged that the subjects' fever due to tumor could be included in the study);
  • Subjects with congenital or acquired immune deficiency (e.g. HIV infected), or active hepatitis (reference: HBsAg, anti-HBS, HBeAg, anti-HBC, anti-HBE, HBV DNA≥10#/ml, liver cell transaminase, etc.); Hepatitis C reference: HCV antibodies and HCVRNA);
  • The subject has a known history of psychotropic drug abuse, alcoholism or drug abuse;
  • In the judgment of the researcher, the subject has other factors that may lead to the termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory examination, family or social factors, which may affect the safety of the subject, or the collection of test data and samples.
  • Women who are pregnant or breastfeeding, or who refuse/cannot accept medically acceptable conditions. For women with potential pregnancy and sexually active men.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Phase III Clinical Trial of Leucogen Versus Placebo on Leukocyte and Platelet Whole-course Management Assisted by Platinum Plus Low-dose Long-term Continuous Intravenous Infused 5-fluorouracil Chemotherapy in the Treatment of Stage IV, Recurrent or Metastatic Nasopharyngeal Carcinoma

Toxic and side effects during and after chemoradiotherapy for nasopharyngeal carcinoma seriously affect patients' treatment compliance and long-term quality of life. Active and effective prediction, prevention and management of toxic and side effects is an important element to improve the prognosis of patients. Leucogen has the ability to promote the growth and maturation of granulocytes in the bone marrow and the proliferation of leukocytes, and is widely used in radiation therapy and chemotherapy-induced leukopenia in malignant carcinomas. In addition, leucogen may have potential anticancer synergistic effects. Therefore, based on the application prospect of leucogen in preventing myelosuppression during chemotherapy for solid tumors, the study was designed to investigate the efficacy and safety of leucogen versus placebo on leukocyte and platelet whole-course management assisted by platinum plus low-dose long-term continuous intravenous infused 5-fluorouracil chemotherapy in the treatment of stage IV, recurrent or metastatic nasopharyngeal carcinoma.

Being tested
5-fu, Lobaplatin, Placebo, leucogen
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • 5-fuDrug

    5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle.

  • LobaplatinDrug

    30mg/m2, used on the 1st and 28th day of each cycle.

  • PlaceboDrug

    2 tablets/dose 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, 3 tablets/dose 3 times daily during chemotherapy, and continued to be given orally 2 tablets/dose 3 times daily for 4 weeks after the end of chemotherapy.

  • leucogenDrug

    40 mg/dose was used 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, and 60 mg/dose was used 3 times daily during chemotherapy, and 40 mg/dose was continued orally 3 times daily for 4 weeks after the end of chemotherapy.

Study groups in NCT05780294
Study groupRoleWhat they receive
Control groupPlacebo comparatorChemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Lobaplatin: 30mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 6 cycles, a total of 12 months. Drug: Placebo After diagnosis of stage IV, recurrent or metastatic nasopharyngeal carcinoma (within 3 weeks before treatment), placebo tablets were started,) 2 tablets/dose 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, 3 tablets/dose 3 times daily during chemotherapy, and continued to be given orally 2 tablets/dose 3 times daily for 4 weeks after the end of chemotherapy. In case of grade III-IV myelosuppression during treatment, recombinant human granulocyte-stimulating factor injection (manufactured by Qilu Pharmaceutical Co., Ltd.) was given again at 2~5ug/kg, subcutaneously once daily, and the clinical trial was terminated.
Receives: Drug: 5-fu; Drug: Lobaplatin; Drug: Placebo
Experimental groupActive comparatorChemotherapy: 5-fu: 200mg/m2/d, continuous intravenous infusion on the 1st to 30th day of each cycle; Lobaplatin: 30mg/m2, used on the 1st and 28th day of each cycle; Q60d; Every 2 months for a treatment cycle, use 6 cycles, a total of 12 months. Drug: Leucogen After the diagnosis of stage IV, recurrent or metastatic nasopharyngeal carcinoma (within 3 weeks before treatment), oral leucogen tablets (manufactured by JIANGSU JIBEIER PHARMACEUTICAL CO.,LTD, 20 mg/tablet) were started and 40 mg/dose was used 3 times for peri-chemotherapy prophylaxis and inter-chemotherapy period, and 60 mg/dose was used 3 times daily during chemotherapy, and 40 mg/dose was continued orally 3 times daily for 4 weeks after the end of chemotherapy. In case of grade III-IV myelosuppression during treatment, recombinant human granulocyte-stimulating factor injection (manufactured by Qilu Pharmaceutical Co., Ltd.) was given again at 2~5ug/kg, subcutaneously once daily, and the clinical trial was terminated.
Receives: Drug: 5-fu; Drug: Lobaplatin; Drug: leucogen

What is being measured

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

  1. Therapeutic toxicity

    Grade I-IV hematological toxicity

    Measured: Up to 3 approximately months

  2. Time of myelosuppression

    From the beginning of treatment to the onset of myelosuppression

    Measured: Up to 3 approximately months

Secondary outcomes (5)

  1. OS

    Overall survival

    Measured: Up to 5 years

  2. PFS

    Progression-free survival

    Measured: Up to 5 years

  3. ORR

    ORR

    Measured: Up to 2 approximately years

  4. DCR

    Disease control rate

    Measured: Up to 2 approximately years

  5. DOR

    Duration of response

    Measured: Up to 2 approximately years

Timeline

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

  1. First posted22 Mar 2023
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Dec 2029 (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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780294
Sponsor's protocol ID
2022-FXY-253
Status last verified
Mar 2023
First submitted
10 Mar 2023
Last updated
22 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-fu, Lobaplatin and leucogen in people with Nasopharyngeal Carcinoma and Leucogen, run by Sun Yat-sen 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 15 inclusion and 13 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: opening soon, as of the sponsor's last update on 22 Mar 2023. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic toxicity (time frame: Up to 3 approximately 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?

On the ClinicalTrials.gov record for NCT05780294.

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 22 Mar 2023.

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