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Nasopharyngeal CarcinomaPhase 2NCT05549466

Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

A Phase 2 study testing Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Apatinib, Camrelizumab and Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Apatinib, Camrelizumab and Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
8 Oct 2022to 20 Sep 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female; 18-70 years of age;
  • Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
  • ECOG performance status of 0 or 1.
  • Progression after previous treatment with platinum-based dual-drug chemotherapy.
  • Progression after previous treatment with PD-1 inhibitors.
  • Experieced at least 1 line systemic therapy.
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  • Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
  • Adequate organ function assessed by laboratory parameters during the screening period
  • Life expectancy more than 12 weeks.
  • Able to understand and sign an informed consent form (ICF).

Who cannot join

  • Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
  • Previous treatment over 2 lines.
  • Patients who had previously received one of the three chemotherapy drugs and were randomly assigned to single-agent chemotherapy (control group) were not eligible to reuse the same treatment in this study. In addition, patients who had previously received all three chemotherapy agents for R/M lesions were excluded from the study.
  • Prior use of any anti-VEGF(R) agents.
  • Patients with other malignancies.
  • Patients with nasopharyngeal necrosis found by endoscope before enrollment or with a > 50% chance of nasopharyngeal necrosis according to the risk prediction model: ① Patients with recurrent stage T3-4 received two courses of radiotherapy before enrollment, or received nasopharyngeal radiotherapy within 1 year before enrollment; ② Patients with recurrent T1-2 stage had received two courses of radiotherapy and nasopharyngeal radiotherapy within 1 year before enrollment.
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  • Patients with or previous with serious hemorrhage (bleeding >30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).
  • Patients with hypertension who cannot be reduced to the normal range by antihypertensive drug treatment (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg), patients with ≥ grade II coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency.
  • Patients with known or suspected autoimmune diseases including dementia and seizures.
  • Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).
  • An excessive dose of glucocorticoids given within 4 weeks before enrollment.
  • Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
  • Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.
  • HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
  • Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
  • Women of childbearing age with a positive pregnancy test and lactating women.
  • Special attention: Patients with active bleeding, ulcers, and bowel perforations within 30 days after major surgery with tumors in close proximity to the internal carotid artery or other major vessels, and those at risk of major bleeding are prohibited.
  • Patients considered unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Ming-Yuan Chen, MD, PhD contact

86-20-8734-3361

chmingy@mail.sysu.edu.cn

Rui You, PhD contact

86-13580439820

yourui@sysucc.org.cn

China1 site, 1 recruiting

  • Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Ming-Yuan Chen, MD,PhD, 86-20-8734-2422, chmingy@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC

Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. Based on previous clinical trials, anti-angiogenic drugs combined with immunotherapy were found to be effective. Therefore, this study intends to preliminarily evaluate which treatment regimen can provide the most benefit to PD-1 inhibitor refractory patients by comparing the efficacy of VEGFR inhibitor or standard chemotherapy combined with PD-1 inhibitor.

Being tested
Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Apatinib, Camrelizumab, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)Drug

    Gemcitabine, iv, 1000 mg/m^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m^2, D1, Q3W.

    Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.

  • Apatinib, CamrelizumabDrug

    Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.

  • Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)Drug

    Gemcitabine, iv, 1000 mg/m^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m^2, D1, Q3W.

    Camrelizumab, iv, 200mg, D1, Q3W.

  • Chemotherapy (gemcitabine/ capecitabine/ docetaxel)Drug

    Gemcitabine, iv, 1000 mg/m^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m^2, D1, Q3W.

Study groups in NCT05549466
Study groupRoleWhat they receive
Apatinib plus Camrelizumab and ChemotherapyExperimentalNot described
Receives: Drug: Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Apatinib plus CamrelizumabExperimentalNot described
Receives: Drug: Apatinib, Camrelizumab
Camrelizumab and ChemotherapyExperimentalNot described
Receives: Drug: Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
ChemotherapyActive comparatorNot described
Receives: Drug: Chemotherapy (gemcitabine/ capecitabine/ docetaxel)

What is being measured

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

  1. Objective response rate (ORR)

    Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.

    Measured: 1 year

Secondary outcomes (5)

  1. Median progression-free survival (PFS)

    Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.

    Measured: 3 years

  2. Median overall survival (OS)

    Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened.

    Measured: 3 years

  3. Duration of response (DoR)

    Defined as the time from first documentation of objective response to radiological disease progression.

    Measured: 3 years

  4. Disease control rate (DCR)

    Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.

    Measured: 1 year

  5. Adverse events

    NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.

    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 posted22 Sep 2022
  2. Study start8 Oct 2022
  3. Primary completion20 Sep 2023 (estimated)
  4. Study completion20 Sep 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05549466
Sponsor's protocol ID
SYSUCC-CMY-2022-0917
Status last verified
Feb 2023
First submitted
17 Sep 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel), Apatinib, Camrelizumab and Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel) in people with Nasopharyngeal Carcinoma, 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 10 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 8 Feb 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. 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 Ming-Yuan Chen, MD, PhD (86-20-8734-3361, chmingy@mail.sysu.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 (ORR) (time frame: 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 NCT05549466.

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 Feb 2023.

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