AzTrials
AzTrials

Nasopharyngeal CarcinomaPhase 2NCT04996758

Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL)

A Phase 2 study testing Toripalimab and Anlotinib in people with Nasopharyngeal Carcinoma and Recurrent or Metastatic Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase 2 trial studies toripalimab and anlotinib combination treatment in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least one line of platinum-based chemotherapy Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Toripalimab and Anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 Oct 2021to 1 Dec 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed undifferentiated non-keratinizing carcinoma
  • Patients suffered failure of at least one line of platinum-based chemotherapy. The definition of treatment failure: progression during or after chemotherapy for recurrence/metastasis; progression after concurrent chemoradiotherapy within 6 months. Withdrawal of treatment due to drug intolerances is excluded ;
  • Without other malignancy;
  • Male or female, 18-70 years;
  • Eastern Cooperative Oncology Group (ECOG) of 0-2;
  • Life expectancy ≥ 3 months;
Show all 13Show fewer
  • Women of childbearing age must obtain the negative result of a pregnancy test (serum or urine) , and they were willing to use reliable methods of contraception during the trial;
  • At least one evaluable lesion；
  • Laboratory tests meet the following standards:
  • Blood routine: White blood cell count (WBC) ≥3.0×10 9 /L, neutrophil count (ANC) ≥1.5×10 9 /L, platelet count (PLT) ≥75×10 9 /L, hemoglobin (HGB) 90 g/L or higher; Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); glutamic-oxalacetic transaminase (AST) and alanine transaminase (ALT) ≤2.5 times ULN, AST and ALT ≤2.5 times ULN for the patients with liver metastases; Alkaline phosphatase ≤5 times ULN; Renal function: Serum creatinine (Cr) ≤1.5 times ULN; Creatinine clearance ≥60mL/min; Urine routine: urine protein <2+ ;baseline urine protein ≥2+ and 24 hours urine protein < 1g ; Coagulation: International normalized ratio (INR) and activated partial thrombin time (APTT) ≤1.5 times ULN; Albumin ≥28g/L Thyroid stimulating hormone (TSH)≤1 times ULN (free triiodothyrosine [FT3] or free thyroxine [FT4] ≤1 times ULN can be included)
  • No serious cardiopulmonary dysfunction;
  • The informed consent has been signed.
  • Ability to comply with test requirements

Who cannot join

  • A known allergy to any of the drugs in the study;
  • Pregnant or breastfeeding women;
  • Participated in clinical trials of other drugs within 4 weeks prior to study initiation;
  • Previous treatment with bevacizumab or VEGFR-family small molecule tyrosine kinase inhibitors (e.g., famitinib, sorafenib, Sunitinib, regofinib, Apatinib, Anlotinib, fuquinitinib) ;
  • Recurrent nasopharyngeal lesions after radiotherapy and who received secondary radiotherapy;
  • Palliative radiotherapy for symptom control within 28 days before enrollment;
Show all 30Show fewer
  • Immunosuppressive treatment with immunosuppressive agent, systemic or absorbable topical hormone therapy ( prednisone or other therapeutic hormone at the dose greater than 10mg/ day) within 2 weeks before enrollment;
  • Active autoimmune diseases, with the necessity of systemic treatment (hormone replacement therapy is not considered as a systemic treatment, such as type 1 diabetes) over the past two years; autoimmune diseases that did not require systemic treatment in the past two years;
  • A history of immunodeficiency, including acquired/congenital immunodeficiency disorders, a history of organ transplantation;
  • Vaccinated with live vaccine (inactivated virus vaccine for seasonal influenza is allowed) within 4 weeks before enrollment;
  • Invasion of important vessels (e.g. surrounding internal carotid artery/vein) on MRI; tumor with a high risk of affecting vital blood vessels during treatment and causing fatal hemorrhage, which is determined by investigators;
  • A history of severe bleeding and any bleeding event with a severity rating of 3 or higher in the NCI CTCAE within 4 weeks prior to screening;
  • Abnormal coagulation (INR > 2.0, PT > 16s) and bleeding tendency (the INR must be within the normal range without anticoagulants during14 days prior to signing the informed consent); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogests; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (up to 100 mg daily) for preventive purposes, provided that the international normalized ratio of prothrombin time (INR) is ≤ 1.5;
  • Unstable angina and/or congestive heart failure or vascular disease with the need of hospital treatment; other cardiac damage that may affect the drug safety;
  • Patients with hypertension that is not well controlled with antihypertensive medication (systolic > 140mmHg, diastolic > 90 mmHg); patients is taking a combination of two or more antihypertensive drugs; Cardiovascular disease with clinical significance， such as cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤ 6 months before randomization), unstable angina, congestive heart failure of NYHA grade II or higher, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on experimental treatments;
  • Patients with esophageal and gastric varices, active ulcers, intestinal perforation or intestinal obstruction within 6 months before enrollment;
  • A history of abdominal fistula, digestive tract perforation, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months before enrollment;
  • Multiple factors affecting oral administration and absorption of drugs (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction);
  • Overoperation/venous thromboembolism events, NCI CTCAE grade 3 or higher venous thromboembolism within 6 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except for those venous thrombosis caused by venous catheterization due to previous chemotherapy and determined to be cured by the researchers ), pulmonary embolism, etc.;
  • Patients with past and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function;
  • Exacerbation of chronic obstructive pulmonary disease (COPD) or other respiratory disease requiring hospitalization within 28 days before enrollment;
  • Active pulmonary infection and/or acute bacterial or fungal infection requiring intravenous antibiotic treatment within 28 days;
  • Dominant jaundice due to abnormal liver function within 7 days;
  • Renal insufficiency: routine urinalproteinuria > 2+ and confirmed 24 h urinary protein quantification > 1.0g;
  • Minor surgical operations (including catheterization, excluding central venous catheterization via peripheral venipuncture) within 2 days before enrollment;
  • Major surgery within 28 days before enrollment;
  • A potent CYP3A4 inhibitor within one week prior to enrollment, or a potent CYP3A4 inducer within two weeks prior to study participation
  • Long-term unhealed wounds or incomplete fractures;
  • Symptomatic central nervous system metastases (e.g. brain edema, need for hormonal intervention, or brain metastases)
  • The presence of serious or uncontrolled infections;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

    Guangzhou, 510030

Other trials in China

About this study

Official title: An Open-Label, Phase Ⅱ Study of Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL)

This phase 2 trial studies toripalimab and anlotinib combination treatment in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least one line of platinum-based chemotherapy

Being tested
Toripalimab and Anlotinib
Medical subject headings
Nasopharyngeal Carcinoma, Recurrence

What participants receive

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

  • Toripalimab and AnlotinibDrug

    Toripalimab 240 mg iv.drip d1; Anlotinib 12mg po qd d1-14.

Study groups in NCT04996758
Study groupRoleWhat they receive
Toripalimab and Anlotinib Combination TreatmentExperimentalPatients receive toripalimab at a dose of 240 mg on day 1 and anlotinib at a dose of 12 mg before breakfast for once-daily on days 1-14. Treatment cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
Receives: Drug: Toripalimab and Anlotinib

What is being measured

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

  1. Objective Response rate

    Objective Response rate will be determined on the basis of investigator assessments

    Measured: 2 years

Secondary outcomes (7)

  1. Disease Control rate

    the proportion of patients who had a best response rating of complete response, partial response, or stable disease will be determined on the basis of investigator assessments

    Measured: 2 years

  2. Progression Free Survival

    The time from the start of treatment to the progression of the tumor or death (due to any cause).

    Measured: 5 years

  3. Overall Survival

    The time from the start of treatment to time of death (due to any cause).

    Measured: 5 years

  4. Complete Response rate

    Complete Response rate will be determined on the basis of investigator assessments

    Measured: 2 years

  5. Partial Response rate

    Partial Response rate will be determined on the basis of investigator assessments

    Measured: 2 years

  6. Duration of Response

    The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).

    Measured: 5 years

  7. Percentage of Participants With Adverse Events

    Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0

    Measured: 5 years

Timeline

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

  1. First posted9 Aug 2021
  2. Study start30 Oct 2021
  3. Primary completion30 Sep 2023
  4. Study completion1 Dec 2024

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04996758
Sponsor's protocol ID
B2021-055
Status last verified
Dec 2024
First submitted
5 Aug 2021
Last updated
12 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Zou Q, Zhao B, Su N, Li Z, Wang X, Liu P, Tian X, Fang X, Cai J, Li L, Liu Y, Xia Y, Cai Q. Toripalimab plus anlotinib in patients with recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm phase 2 trial (TORAL). Cell Rep Med. 2024 Dec 17;5(12):101833. doi: 10.1016/j.xcrm.2024.101833. Epub 2024 Nov 29.

    PubMed 39615484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab and Anlotinib in people with Nasopharyngeal Carcinoma and Recurrent or Metastatic 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 13 inclusion and 30 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: finished, as of the sponsor's last update on 12 Dec 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response rate (time frame: 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 NCT04996758, 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 12 Dec 2024.

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