Nasopharyngeal CarcinomaPhase 2NCT04955886
Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing Surufatinib(HMPL-012) in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 2 sites in China.
Trial summary
A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Surufatinib(HMPL-012)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2021to Aug 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed that Recurrent or Metastatic Nasopharyngeal Carcinoma.
- Patients must have received at least one standard platinum-based systemic chemotherapy regimen for the treatment of recurrent or metastatic NPC;Or the insensitivity or intolerance to platinum when the patient has previously received radical therapy;
- Not suitable for local treatment (no radiotherapy or surgery);
- Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- Screening laboratory values must meet the following criteria (within past 14 days):
- neutrophils ≥1.5×109/L ;
- platelets ≥100×109/L；
- hemoglobin ≥ 10 g/dL;
- total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5╳ULN;
- Ability to follow the program;
- Toxic side effects of any previous chemotherapy have returned to less than or equal to NCI CTCAE1 level or baseline;
- Predicted survival >3 months;
- Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 6 months after the last dose of study drug.
Who cannot join
- The pathological type was neuroendocrine or small cell carcinoma;
- Evidence with active CNS disease or previous brain metastases;
- Prior received anti-tumor monoclonal antibodies or other investigational drugs within the first 4 weeks of enrollment;Previous treatment with other anti-PD-1 antibodies or other treatments targeting PD-1 / PD-L1.
- Prior treatment with Surufatinib,or other antiangiogenic drugs were used ;
- Patients were on immunosuppressive or systemic hormone therapy (doses greater than 10mg/day prednisone or other equivalent hormone) for immunosuppressive purposes and were still on it within 2 weeks prior to enrolment;
- The patient has any active autoimmune disease or a history of autoimmune disease;
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- Have clinical cardiac symptoms or diseases that are not well controlled;
- Patients with congenital or acquired immune deficiency;
- Chemotherapy, targeted therapy and radiotherapy were received within 2 weeks before enrollment;
- Patients who had a history of gastrointestinal perforation or had undergone major surgery 4 weeks before enrollment;
- During the first 6 months of enrollment, there were arterial/venous thrombosis events, such as non-cardiovascular and cerebrovascular (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization during pre-chemotherapy, which was determined by the investigators to be cured), and pulmonary embolism;
- Patients with abnormal coagulation function (International normalized ratio (INR) >1.5 or partially activated prothrombin time (APTT) >1.5×ULN), bleeding tendency (such as active ulcer lesions in the stomach, occlusive blood in the stool (++), melenia and/or hematemesis and hemoptysis within 3 months) or lesions close to large vessels.The lesions involved in the skin or mucosal cavity are at risk of rupture;
- Hypertension that cannot be controlled by medication;
- Routine urine indicated more than 2+ urine protein or 24 hours urine protein >150mg/L;
- Calibration of QT interval > 470MSEC;If the patient has an extended QT interval, but the investigator's study evaluates the prolonged period as due to a pacemaker (and no other cardiac abnormality), it is up to the investigator to determine whether the patient is eligible for the study;
- Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
- Known to be allergic to drug ingredients;
- Patients at risk of massive bleeding in the nasopharynx or deep ulcers in the nasopharynx.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Affiliated Cancer Hospital of Sun Yat-sen University
Guangdong
Fei Han, MD, 13822113698, hanfei@sysucc.org.cn
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai
Guopei Zhu, MD, 13774338182, antica@gmail.com
About this study
Official title: Efficacy and Safety of Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma : a Prospective, Single Arm and Multicenter Trial
A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.
Read the detailed description
This study adopt Simon's two-stage Optimal designs method based on the primary endpoint of objective response rates. 4 patients were planned for the first stage. If one or more responses were observed, an additional 8 patients were to be accrued for a total of 12 patients. If 4 or more of the 12 patients achieved an objective response, then this study was designated worthy of additional investigation.Considering a 10% abscission rate, a total of 14 patients were included.
Surufatinib（250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Surufatinib(HMPL-012)
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib(HMPL-012)Drug
Also called Toripalimab
Surufatinib(250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
| Study group | Role | What they receive |
|---|---|---|
| Recurrent or Metastatic Nasopharyngeal Carcinoma. | Experimental | Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma were given Surufatinib Combined With Toripalimab. Receives: Drug: Surufatinib(HMPL-012) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Secondary outcomes (4)
Progression Free Survival (PFS)
To assess the efficacy of Surufatinib and Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma. patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: up to 12 months
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Measured: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Duration of relief (DOR)
The length of time that a tumor continues to respond to treatment without the cancer growing or spreading.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sufang Qiu, MD, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955886
- Sponsor's protocol ID
- HMPL-012-SPRING-HNC104
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma : a Prospective, Single Arm and Multicenter Trial
- ClinicalTrials.gov ID
- NCT04955886
- Acronym / sponsor ID
- HMPL-012-SPRING-HNC104
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm,mutil-center study to assess the efficacy and safety of Surufatinib combined with Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma.
Detailed description
This study adopt Simon's two-stage Optimal designs method based on the primary endpoint of objective response rates. 4 patients were planned for the first stage. If one or more responses were observed, an additional 8 patients were to be accrued for a total of 12 patients. If 4 or more of the 12 patients achieved an objective response, then this study was designated worthy of additional investigation.Considering a 10% abscission rate, a total of 14 patients were included.
Surufatinib（250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent or Metastatic Nasopharyngeal Carcinoma. | Experimental | Drug: Surufatinib(HMPL-012)Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma were given Surufatinib Combined With Toripalimab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
- Male and Female aged between 18 and 75 years are eligible;
- Histologically or cytologically confirmed that Recurrent or Metastatic Nasopharyngeal Carcinoma.
- Patients must have received at least one standard platinum-based systemic chemotherapy regimen for the treatment of recurrent or metastatic NPC;Or the insensitivity or intolerance to platinum when the patient has previously received radical therapy;
- Not suitable for local treatment (no radiotherapy or surgery);
Key exclusion criteria (18 listed)
- The pathological type was neuroendocrine or small cell carcinoma;
- Evidence with active CNS disease or previous brain metastases;
- Prior received anti-tumor monoclonal antibodies or other investigational drugs within the first 4 weeks of enrollment;Previous treatment with other anti-PD-1 antibodies or other treatments targeting PD-1 / PD-L1.
- Prior treatment with Surufatinib,or other antiangiogenic drugs were used ;
- Patients were on immunosuppressive or systemic hormone therapy (doses greater than 10mg/day prednisone or other equivalent hormone) for immunosuppressive purposes and were still on it within 2 weeks prior to enrolment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surufatinib(HMPL-012)Also: ToripalimabSurufatinib(250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met . | Drug | Recurrent or Metastatic Nasopharyngeal Carcinoma. |
Primary outcome
Objective response rate (ORR)
Time frame: up to 12 months
CR + PR rate according to the RECIST version 1.1 guidelines.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: up to 12 months
Overall survival time
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Time frame: up to 12 months
Duration of relief (DOR)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sufang Qiu, MD principal investigator
Fujian Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib(HMPL-012) in people with Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital at 2 sites 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 16 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sufang Qiu, MD (13609589163, sfqiu@126.com), 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: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2021.