NCT05724355

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

February 2, 2023

Last Update Submit

February 2, 2023

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (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.

    1 year

Secondary Outcomes (5)

  • Median progression-free survival (PFS)

    1 year

  • Median overall survival (OS)

    3 years

  • Duration of response (DoR)

    1 year

  • Disease control rate (DCR)

    1 year

  • Incidence of adverse events

    1 year

Study Arms (1)

Dalpiciclib plus Camrelizumab

EXPERIMENTAL
Drug: Dalpiciclib Isetionate Tablets, Camrelizumab

Interventions

Dalpiciclib Isetionate Tablets, CamrelizumabDRUG

Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.

Dalpiciclib plus Camrelizumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
  • 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.
  • 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).
  • Able to swallow the pill.

You may not qualify if:

  • Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
  • Previous treatment over 3 lines.
  • Prior use of CDK4/6 inhibitors.
  • Patients with other malignancies.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

86-20-8734-3361chmingy@mail.sysu.edu.cn

Rui You, PhD

CONTACT

86-13580439820yourui@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician, Professor

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2024

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

CN(1)