Surufatinib Combined With Toripalimab in Recurrent or Metastatic Nasopharyngeal Carcinoma

NCT04955886 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-HNC104
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  CR + PR rate according to the RECIST version 1.1 guidelines.

  up to 12 months

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  up to 12 months

• Overall survival time

  up to 36 months

• Assess the anti-tumor activity:DCR

  up to 12 months

• Duration of relief (DOR)

  through study completion, an average of 1 year

Study Arms (1)

Recurrent or Metastatic Nasopharyngeal Carcinoma.

EXPERIMENTAL

Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma were given Surufatinib Combined With Toripalimab.

Drug: Surufatinib(HMPL-012)

Interventions

Surufatinib(HMPL-012) DRUG

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 .

Also known as: Toripalimab

Recurrent or Metastatic Nasopharyngeal Carcinoma.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (2)

Affiliated Cancer Hospital of Sun Yat-sen University

Guangdong, China

Location

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sufang Qiu, MD

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sufang Qiu, MD

CONTACT

13609589163; sfqiu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 9, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (2)