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AzTrials

Nasopharyngeal CarcinomaPhase 2/3NCT04890522

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

A Phase 2/3 study testing Triprilimab(JS001), Cisplatin and 5-Fluorouracil in people with Nasopharyngeal Carcinoma and Metastasis, 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

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Nasopharyngeal Carcinoma, Metastasis, Chemotherapy
What is being tested?
Triprilimab(JS001), Cisplatin and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
622 participants
Where
1 siteChina
Study dates
1 Jul 2021to 31 Dec 2028
Phase
Phase 2/3
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

  • Nasopharyngeal carcinoma diagnosed by pathology or cytology.
  • Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) is not amenable for local-regional treatment or curative treatment.
  • Has not received prior systemic treatment for metastatic nasopharyngeal carcinoma, except for neoadjuvant chemotherapy, concurrent chemoradiotherapy, or adjuvant chemotherapy 6 months prior to the first treatment.
  • The Karnofsky performance status score is at least 70 points (if the decreased score is caused by the tumor, the minimum score can be 50 points after the judgment of researchers.)
  • Has at least one measurable target lesion based on RECIST v1.1, which is never received local treatment like radiotherapy.
  • Life expectancy ≥ 3 months.
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  • The lab examination results of the screening must fulfill all of the following (use of any blood components, hematopoietic stimulating factors, etc. are not allowed within 14 days before screening):
  • absolute neutrophil count ≥1.5×10^9/ L;
  • platelet count ≥ 100×10^9/ L;
  • hemoglobin ≥ 8.0 g/dL;
  • serum albumin ≥ 2.8g/dL;
  • aspartate transferase(AST) and alanine transferase(ALT) ≤ 1.5 ×ULN; total bilirubin ≤ 1.5×ULN (if has liver metastasis, AST and ALT ≤ 5×ULN);
  • creatinine clearance >50 mL/min.
  • Men with reproductive capacity or women of childbearing potential must use highly effective contraceptive methods during the trial (e.g., oral contraceptives, intrauterine device, sexual abstinence or barrier method combined with spermicide), and continue contraception for 3 months after the last injection of JS001 and 6 months after the end of chemotherapy.
  • Has signed the Informed Consent Form.

Who cannot join

  • Allergic to monoclonal antibodies, any JS001 components, gemcitabine, cisplatin, or 5-fluorouracil.
  • Has prior therapy including anti-PD-1, anti-PD-L1, or CTLA4.
  • Major surgery within 28 days prior to the randomization (not including diagnostic surgery) or plan to be conducted during the study.
  • Active autoimmune disease requiring systemic treatment or has a history of autoimmune disease.
  • Requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment.
  • Allergic to macromolecular protein preparation ingredients.
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  • Has central nervous system (CNS) metastasis with clinical symptoms.
  • Had other invasive malignant diseases, except excised basal-cell skin carcinoma, cervical carcinoma in situ, or other cancers curatively treated more than 5 years before study entry.
  • Has cardiac clinical symptoms or disease out of control.
  • Has an active infection or unexplained fever with more than 38.5 ℃ during screening and prior to first administration.
  • Has acquired or congenital immune-deficient disease, or active hepatitis.
  • History of drug abuse or alcohol abuse.
  • The investigator judges other factors that may lead to the forced termination of this study, including but not limited to: other serious conditions (including mental disorder) that require concomitant treatment, severe laboratory test abnormalities, family or social factors that may affect the safety of patients or the collection of trial data and samples.
  • Pregnancy or breast feeding.

Trial locations and contacts

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

Yun-fei Xia, MD contact

+8613602805461

xiayf@sysucc.org.cn

Shuohan Zheng, MD contact

+8613826478924

zhengsh1@sysucc.org.cn

China1 site

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

    Guangzhou, Guangdong, 510060

    Yun-fei Xia, MD, +8613602805461, xiayf@sysucc.org.cn

    Shuohan Zheng, MD, +8613826478924, zhengsh1@sysucc.org.cn

Other trials in China

About this study

Official title: A Randomized, Open-label, Multicentre, Phase II/III Study of Low-dose Long-term Continuous Intravenous Infused 5-fluorouracil Versus Gemcitabine Combined With Cisplatin and JS001 as First-line Therapy for Metastatic Nasopharyngeal Carcinoma

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.

Being tested
Triprilimab(JS001), Cisplatin, 5-Fluorouracil, Gemcitabine
Medical subject headings
Nasopharyngeal Carcinoma, Neoplasm Metastasis

What participants receive

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

  • Triprilimab(JS001)Drug

    Maximum 6 cycles for combined therapy and maintenance for up to 2 years.

  • CisplatinDrug

    Maximum 6 cycles for combined therapy.

  • 5-FluorouracilDrug

    Maximum 6 cycles for combined therapy.

  • GemcitabineDrug

    Maximum 6 cycles for combined therapy.

Study groups in NCT04890522
Study groupRoleWhat they receive
Experimental groupExperimental5-fluorouracil intravenous infusion at 200mg/m2/d for 30 continuous days, and intravenous infusion of cisplatin 80 mg/m2 on day 1 and day 28, and intravenous infusion of JS001 240mg on day 1 and day 21, every 60 days.
Receives: Drug: Triprilimab(JS001); Drug: Cisplatin; Drug: 5-Fluorouracil
Control groupActive comparatorgemcitabine at a dose of 1,000 mg/m2 by intravenous infusion on days 1, 8, and intravenous infusion of cisplatin at a dose of 80 mg/m2 on day 1, and intravenous infusion of JS001 240mg on day 1, every 21 days.
Receives: Drug: Triprilimab(JS001); Drug: Cisplatin; Drug: Gemcitabine

What is being measured

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

  1. PFS

    Progression-free survival

    Measured: Up to 5 years

  2. OS

    Overall survival

    Measured: Up to 5 years

  3. Severe drug-related adverse events

    grade III-V according to CTCAE v4.0

    Measured: Up to 2 approximately years

Secondary outcomes (7)

  1. ORR

    Objective response rate

    Measured: Up to 2 approximately years

  2. DCR

    Disease control rate

    Measured: Up to 2 approximately years

  3. DOR

    Duration of response

    Measured: Up to 2 approximately years

  4. Minor drug-related adverse events

    grade I-II according to CTCAE v4.0

    Measured: Up to 2 approximately years

  5. Quality-adjusted survival

    Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST), a measure involving the partitioning of survival duration into clinically relevant health states (e.g., treatment toxicity, disease progression, progression-free), assigning preference weights (or utilities) to these health states, and calculating quality of life-adjusted weighted sums of the mean duration of each health state to create the overall Q-TWiST scores.

    Measured: Up to 5 years

  6. Therapeutic gain

    Calculated by dividing person-year rate of overall survival by person-year rate of serious toxicity.

    Measured: Up to 2 approximately years

  7. Incremental Cost-Effectiveness Ratio (ICER)

    To estimate the costs and health gains of different interventions, calculated as incremental cost divided by life years gained.

    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 posted18 May 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2028 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
622 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890522
Sponsor's protocol ID
B2020-409-01
Status last verified
May 2021
First submitted
4 May 2021
Last updated
18 May 2021
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 2/3 study testing Triprilimab(JS001), Cisplatin and 5-Fluorouracil in people with Nasopharyngeal Carcinoma and Metastasis, 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 14 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 18 May 2021. 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 combined 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.

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?

Contact Yun-fei Xia, MD (+8613602805461, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Up to 5 years). The study lists 3 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 NCT04890522.

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 18 May 2021.

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