AzTrials
AzTrials

Nasopharyngeal CarcinomaPhase 2NCT04917770

The Efficacy and Safety of Sintilimab in Combination With Multimodal Radiotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Sintilimab in combination with Multimodality Radiotherapy in people with Nasopharyngeal Carcinoma, run by West China Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Nasopharyngeal carcinoma is the most common malignant tumor of head and neck in southern China. After standard treatment, about 20% of the patients had local recurrence or distant metastasis, and the patients faced death in a short time. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Sintilimab in combination with Multimodality Radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
30 Jun 2021to 30 Jun 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The histopathological diagnosis was recurrent or distant metastatic nasopharyngeal carcinoma;
  • Have received two or more lines of treatment, including at least one immunocheckpoint inhibitor related therapy containing PD-1/L1, and have achieved clinical benefit;
  • Aged between 18 and 65 at the date of signing the informed consent;
  • ECOG score 0-1;
  • At least ≥1 measurable lesion according to Recist v1.1, or ≥1 measurable lesion with definite progression after local treatment (based on Recist v1.1 criteria);At the same time, there were more than 1 radiotherapy foci and lesions with radiographic evaluation of distant effect.
  • Life expectancy ≥12 weeks;
  • Major organ functions within 28 days prior to treatment meet the following criteria:
  • Routine blood test criteria (without blood transfusion within 14 days) : hemoglobin (Hb) ≥80g/L;Neutrophils absolute value (ANC) ≥1.5×109/L;Platelet (PLT) ≥80×109/L; B. Biochemical tests should meet the following criteria: total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN;Serum creatinine (CR) ≤1.5×ULN or creatinine clearance rate (CCR)≥60ml/min; C. Coagulograms should meet the following criteria: International Standardized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5ULN;Activated partial thromboplastin time (APTT) ≤1.5 ULN (if the patient is receiving anticoagulant therapy, as long as PT and APTT are within the expected treatment range); D. centrifuge markers and urinary natriuretic peptide (BNP) ≤ULN; E. Thyroid function: T3 and T4 levels were normal after medication; 8. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for 120 days after the end of the study;Negative serum or urinary pregnancy test within 7 days prior to study enrollment; 9. With my consent and signed the informed consent.

Who cannot join

  • Previous use of immunocheckpoint inhibitors combined with radiotherapy after recurrence and metastasis;
  • A history of other malignant tumors within the previous 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and papillary carcinoma of the thyroid;
  • known allergic reactions to active ingredients of PD-1 monoclonal antibody or any excipients;
  • Symptomatic central nervous system metastasis;
  • Those who had received potent CYP3A4 inhibitor treatment within one week before enrollment, or inducer CYP3A4 treatment within two weeks before enrollment;
  • The New York Heart Association's cardiac function classification is Grade III-IV congestive heart failure;
Show all 22Show fewer
  • An ischemic cardiovascular event occurred within 1 year prior to treatment;
  • QT interval of ECG >500 ms;
  • Have received systemic immunosuppressive therapy;
  • Participate in clinical trials of other interventional drugs within 4 weeks before the first administration;
  • Subjects who require systematic treatment with corticosteroids (greater than 10mg equivalent daily dose of prednisone) or other immunosuppressant within 2 weeks prior to the first use of the study drug;
  • Have received an anti-tumor vaccine or a live vaccine within 4 weeks before the first administration of the investigational drug;
  • Major surgery or severe trauma within 4 weeks before the first use of the study drug;
  • Severe infections (CTCAE > grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization;Baseline chest imaging examination suggests active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics);
  • Have a history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);Autoimmune-mediated hypothyroidism treated with a steady dose of thyroid-replacement hormone and with a steady dose of insulin in type 1 diabetes were included;This does not include patients with vitiligo or cured childhood asthma/allergies who do not need any intervention as adults;
  • Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or bone marrow transplantation;
  • History of non-infectious pneumonia
  • Patients with active tuberculosis infection found by medical history or CT examination, or patients with active tuberculosis infection found within 1 year before enrollment, or patients with active tuberculosis infection found before 1 year but without formal treatment;
  • Subsubjects had active hepatitis (HBV DNA≥2000IU/ mL or 10000 copies/ mL) and hepatitis C (HCV antibody positive and HCV-RNA above the detection limit of the assay method);
  • A history of known abuse of psychotropic substances, alcoholism and drug abuse;
  • Being pregnant or lactating;
  • There is any history, disease, treatment, or abnormal laboratory result that may interfere with the results of the study and prevent subjects from participating fully in the study, or the investigator deems that participation is not in the best interest of the subjects.

Trial locations and contacts

No sites are listed yet.

Xingchen Peng, Ph.D contact

18980606753

pxx2014@scu.edu.cn

About this study

Official title: The Efficacy and Safety of Sintilimab in Combination With Multimodal Radiotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Multi-line Treatment (Including Immunotherapy)

Nasopharyngeal carcinoma is the most common malignant tumor of head and neck in southern China. After standard treatment, about 20% of the patients had local recurrence or distant metastasis, and the patients faced death in a short time. Currently, there is no recommended treatment for patients with recurrent or metastatic nasopharyngeal carcinoma who have unsatisfactory results of first-line chemotherapy and subsequent immunotherapy. Patients who have failed multiline therapy have a low survival rate and no drugs are available.This project aims to evaluate the efficacy and safety of sintilimab in combination with multimodal radiotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously received immunotherapy and still progress after multiline therapy, and to seek a new therapeutic approach for such patients.

Being tested
Sintilimab in combination with Multimodality Radiotherapy
Keywords
Sintilimab, nasopharyngeal carcinoma
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Sintilimab in combination with Multimodality RadiotherapyDrug

    Participants will be treated with sintilimab in combination with multimodality radiotherapy

Study groups in NCT04917770
Study groupRoleWhat they receive
Sintilimab in combination with Multimodality Radiotherapy groupExperimentalThe dose of sintilimab was 200mg per dose, intravenously, once every 3 weeks. Multimodal radiotherapy methods: ①SBRT: ≥1 independent lesion was selected, with a single dose of 8-10Gy and a total dose of 40-60Gy, divided into 5-6 times of radiotherapy. The final frequency and total dose of radiotherapy were determined by the radiologist.② Low-dose radiotherapy: ≥1 independent lesion was selected, and the single dose, the final frequency of radiotherapy and the total dose were determined by the radiologist.
Receives: Drug: Sintilimab in combination with Multimodality Radiotherapy

What is being measured

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

  1. Objective response rate

    Measured: up to approximately 2 years

Secondary outcomes (5)

  1. Progression-free survival

    Measured: up to approximately 2 years

  2. Overall survival

    Measured: up to approximately 2 years

  3. Duration of remission

    Measured: up to approximately 2 years

  4. 1 year overall survival

    Measured: 1 years after treatment finished

  5. Adverse reactions

    Measured: Time Frame: from the first drug administration to within 30 days for the last therapy

Timeline

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

  1. First posted8 Jun 2021
  2. Study start30 Jun 2021 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jun 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
Model description
Sintilimab in combination with Multimodality Radiotherapy group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04917770
Sponsor's protocol ID
HX20210601
Status last verified
Jun 2021
First submitted
2 Jun 2021
Last updated
8 Jun 2021
Results posted
No
Data monitoring committee
Yes
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 study testing Sintilimab in combination with Multimodality Radiotherapy in people with Nasopharyngeal Carcinoma, run by West China Hospital.

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 8 inclusion and 22 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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 Xingchen Peng, Ph.D (18980606753, pxx2014@scu.edu.cn), 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 approximately 2 years). 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 NCT04917770.

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 8 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in