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Disease-free Survival RatePhase 2NCT04782765

Phase Ⅱ Trial of Camrelizumab in Patients Without Distant Metastasis Nasopharyngeal Carcinoma

A Phase 2 study testing Camrelizumab+Chemotherapy+Chemoradiotherapy in people with Disease-free Survival Rate, run by Tianjin Medical University Cancer Institute and Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

To see the effect if a combination of neoadjuvant chemotherapy combined with Camrelizumab followed by chemoradiotherapy in treating patients without distant metastasis nasopharyngeal carcinoma Read more about this study

Who is it for?
Ages Up to 70 years
Conditions the study is for
Disease-free Survival Rate
What is being tested?
Camrelizumab+Chemotherapy+Chemoradiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteChina
Study dates
20 Mar 2021to 20 Mar 2025
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 Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Sign written informed consent before enrollment;
  • Male or female under the age of 70;
  • Diagnosed by imaging examination and histopathologic examination Ⅱ I - Ⅳ b period in patients with nasopharyngeal carcinoma
  • No first-line treatment has been received
  • ECOG/PS score: 0 ~ 1;
  • Expected survival is greater than 12 weeks;
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  • The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) :
  • Routine blood examination (no blood transfusion or use of hematopoietic stimulant subclass drugs to correct within 14 days before screening) Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Absolute value of lymphocyte count (LC) ≥0.5×109/L; Platelet count (PLT) ≥100×109/L; White blood cell count (WBC) ≥4.0×109/L and ≤15×109/L;
  • Biochemistry (no blood transfusion or albumin within 14 days prior to screening) AST and ALT ≤2.5 x ULN ALP ≤ 2.5 x ULN TBiL≤ 1.5 x ULN ALB≥30 g/L; Cr≤1.5×ULN, and creatinine clearance rate (CrCl)≥80 mL/min (Cockcroft-Gault formula)
  • Normal coagulation function, no active bleeding and thrombotic disease A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN; C. Prothrombin time Pt ≤1.5×ULN;
  • For women of non-surgical sterilization or reproductive age, use of a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during the study treatment period and within 3 months after the end of the study treatment period;Women of reproductive age who are not surgically sterilized must be negative for serum or urine HCG within 7 days prior to study enrolment;And must be non-lactation;Male patients who are not surgically sterilized or of reproductive age need to agree to use a medically approved method of contraception with their spouse for the duration of the study treatment period and for three months after the end of the study treatment period.
  • Subjects volunteered to participate in this study, with good compliance, safety and survival follow-up.

Who cannot join

  • Previous radiation, chemotherapy, hormone therapy, surgery, or molecular targeted therapy;
  • Imaging confirmed patients with distant metastasis;
  • Subjects have previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • Previous treatment with carrelizumab or other PD-1/PD-L1 inhibitors was not included;Subject is known to have a prior allergy to macromolecular protein formulations or to any of the carrizumab or chemotherapy ingredients used by the subject during neoadjuvant therapy;
  • there is no active participants autoimmune disease or a history of autoimmune diseases (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function is reduced, always had thyroid surgery must be incorporated into;Subjects with vitiligo or asthma that had been in complete remission during childhood were enrolled as adults without any intervention;Asthmatic subjects requiring bronchodilators for medical intervention were not included);
  • Subjects are using immunosuppressants and continue to use them within 2 weeks before enrolment;
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  • Patients with clinical cardiac symptoms or diseases that are not well controlled, such as :(1) NYHA2 heart failure or above, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • Abnormal coagulation function (PT>16 s, APTT>43S, TT>21 s, Fbg>2g/L) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • Previous or current severe bleeding (bleeding within 3 months >30 ml), hemoptysis (within 4 weeks >5 ml fresh blood) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months;
  • Subjects were still using TCM immunomodulator 2 weeks before enrollment;
  • Subjects have active infection or unexplained fever during screening or prior to first administration >38.5 degrees (subject fever due to tumor can be included, as determined by the investigator);
  • Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.;Subjects who still had grade ≥2 peripheral neuropathy within 3 days before the first medication;
  • Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥1000 IU/ml;Reference for hepatitis C: HCV RNA≥1000 IU/ml); Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ mL must receive antiviral therapy during the trial to be enrolled.
  • Live vaccine was administered less than 4 weeks before or possibly during the study period;
  • Subject has a known history of psychotropic substance abuse, alcohol abuse or drug abuse;
  • Subjects received traditional Chinese medicine treatment within 4 weeks before the first treatment;
  • Subject is unable or does not agree to bear the cost of examination and treatment at their own expense, except for clinical investigational drugs, combined chemotherapy and SAE related to clinical investigational drugs combined chemotherapy;
  • Researchers think that should be left out in this study, the researchers determine, for example, the subjects have other factors that may result in this study were forced to midway termination, such as, other serious disease (including mental illness) need to merge treatment, there are serious abnormal laboratory examination, accompanied by factors such as family or society, will affect the safety of the subjects, or information and the collection of the sample.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Peiguo Wang

    Tianjin, Tianjin Municipality, 300000

    Peiguo Wang, doctor, 18622221196, 18526812877@163.com

    Ruijun Kang, 18360697909, hrkangruijun@163.com

    Recruiting

Other trials in China

About this study

Official title: Phase Ⅱ Trial of Neoadjuvant Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Patients Without Distant Metastasis Nasopharyngeal Carcinoma

To see the effect if a combination of neoadjuvant chemotherapy combined with Camrelizumab followed by chemoradiotherapy in treating patients without distant metastasis nasopharyngeal carcinoma

Read the detailed description

The primary objective of this phase 2 study is to assess disease-free survival rate of 3 years in patients with NPC. The secondary objective is to observe objective response rate, progression free survival, overall survival and safety

Being tested
Camrelizumab+Chemotherapy+Chemoradiotherapy

What participants receive

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

  • Camrelizumab+Chemotherapy+ChemoradiotherapyDrug

    Patients received neoadjuvant Camrelizumab 200mg combined with chemotherapy (Cisplatin 20mg/m2, Day 1-3, Docetaxel 75mg/m2, Day 1) for 2 cycles every 21 days, followed by concurrent chemoradiotherapy with Camrelizumab monotherapy maintenance

Study groups in NCT04782765
Study groupRoleWhat they receive
Camrelizumab+Chemotherapy+ChemoradiotherapyExperimentalPatients received neoadjuvant Camrelizumab 200mg combined with chemotherapy (Cisplatin 20mg/m2, Day 1-3, Docetaxel 75mg/m2, Day 1) for 2 cycles every 21 days, followed by concurrent chemoradiotherapy with Camrelizumab monotherapy maintenance
Receives: Drug: Camrelizumab+Chemotherapy+Chemoradiotherapy

What is being measured

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

  1. Disease-free survival（DFS）rate of 3 years

    Disease-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

    Measured: 3 years

Secondary outcomes (4)

  1. Overall survival(OS)

    The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

    Measured: 3 years

  2. Overall response rate

    Tumour response was classified according to RECIST, version 1.1

    Measured: 16 weeks after completion of concurrent chemoradiotherapy

  3. Distant metastasis-free survival(DMFS) rate of 3 years

    The DMFS rate is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

    Measured: 3 years

  4. Incidence of adverse events

    Incidence of adverse events is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE)5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme

    Measured: 3 years

Timeline

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

  1. First posted4 Mar 2021
  2. Study start20 Mar 2021 (estimated)
  3. Primary completion20 Mar 2023 (estimated)
  4. Study completion20 Mar 2025 (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
59 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782765
Sponsor's protocol ID
OBU-TJ-CC-HNC-II-002
Status last verified
Mar 2021
First submitted
2 Mar 2021
Last updated
4 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Z, Sun Y, Wang Q, Chai Y, Sun J, Zhang X, Wang Q, Wang W, Wang P. Induction chemotherapy plus camrelizumab combined with concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma in non-endemic areas: a phase 2 clinical trial in North China. BMC Med. 2025 Feb 27;23(1):126. doi: 10.1186/s12916-025-03964-9.

    PubMed 40016735

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab+Chemotherapy+Chemoradiotherapy in people with Disease-free Survival Rate, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 18 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 4 Mar 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 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival（DFS）rate of 3 years (time frame: 3 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 NCT04782765, which also lists 1 linked publication.

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 4 Mar 2021.

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