Trial Title:
Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma
NCT ID:
NCT06364826
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Bevacizumab
Gemcitabine
Conditions: Keywords:
locoregionally advanced Nasopharyngeal carcinoma
sintilimab
bevacizumab
IMRT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab, bevacizumab, gemcitabine
Description:
This is a prospective, single-center, single-arm, phase II clinical study. The study was
intended to include patients with locoregionally advanced nasopharyngeal cancer
identified by histology or cytology, who signed informed consent and met the screening
criteria to enter the study. Patients will receive induction therapy (sintilimab +
bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation
therapy with sintilimab continued after radiotherapy until disease progression,
intolerable toxicity, death, or the subject's decision to withdraw from the study, with a
total treatment period of no more than 12 cycles.
Arm group label:
Sintilimab, bevacizumab, gemcitabine
Intervention type:
Radiation
Intervention name:
IMRT
Description:
IMRT
Arm group label:
Sintilimab, bevacizumab, gemcitabine
Summary:
This is a prospective, single-center, single-arm, phase II clinical study. The study was
intended to include patients with locoregionally advanced nasopharyngeal cancer
identified by histology or cytology, who signed informed consent and met the screening
criteria to enter the study. Patients will receive induction therapy (sintilimab +
bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation
therapy with sintilimab continued after radiotherapy until disease progression,
intolerable toxicity, death, or the subject's decision to withdraw from the study, with a
total treatment period of no more than 12 cycles.
Detailed description:
Platinum deplatinization has been extensively explored in patients with posterior
nasopharyngeal carcinoma who have received multiple platinum treatments, including
target-free combination, GEP, etc. Our center also published in 2022 CSCO a study on the
preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line
treatment of metastatic NPC with or without cisplatin or anlotinib. Enrolled patients
were treated with pembrolizumab + anlotinib +GP (group A), pembrolizumab +GP (group B),
and pembrolizumab + anlotinib +G (group C), with ORR of 80% (4/5), 80% (4/5), and 100%
(7/7), respectively. Among them, there were 1 CR and 6 PR in group C. Compared to group
B, group C with anlotinib in place of cisplatin showed a better safety profile with fewer
grade 3 adverse reactions (57.1% vs 100%). In summary, we designed this study to evaluate
the efficacy and safety of gemcitabine, sintilimab and bevacizumab combined with IMRT in
patients with advanced nasopharyngeal carcinoma not suitable for platinum-based
treatment, and to explore new therapeutic approaches for patients with advanced stage
nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive
platinum therapy.
This is a prospective, single-center, single-arm, phase II clinical study. The study was
intended to include patients with locoregionally advanced nasopharyngeal cancer
identified by histology or cytology, who signed informed consent and met the screening
criteria to enter the study. Patients will receive induction therapy (sintilimab +
bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation
therapy with sintilimab continued after radiotherapy until disease progression,
intolerable toxicity, death, or the subject's decision to withdraw from the study, with a
total treatment period of no more than 12 cycles.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Sign a written informed consent before implementing any procedures related to
the trial; 2. No gender limitation, age ≥18 years old, ≤75 years old; 3.
Histological or cytological determination of advanced nasopharyngeal carcinoma
assessed by the investigator without any treatment (stage III-IVA, except
T3N0M0); 4. Not suitable for platinum therapy (patients > 70 years old, PS > 2,
hearing impairment, renal insufficiency (creatinine clearance < 50ml/min) or
grade 1 neuropathy;2023 CSCO Guidelines for the Diagnosis and Treatment of Head
and Neck Tumors) or patients do not receive platinum therapy; 5. The ECOG PS
score is 0-1; 6. According to the solid tumor efficacy evaluation criteria
(RECIST version 1.1), there is at least one radiographically measurable lesion;
7. Expected survival time > 6 months; 8. Adequate organ function.
Exclusion Criteria:
-
1. Patients with uncured malignancies other than advanced nasopharyngeal carcinoma
diagnosed within 5 years prior to initial administration (excluding radical
basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin,
and/or carcinoma in situ after radical resection); 2. Is currently
participating in an interventional clinical study, or has received other
investigational drugs or used investigational devices within 4 weeks prior to
initial dosing; 3. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2
drugs or drugs that target another stimulus or synergistically inhibit T cell
receptors (e.g., CTLA-4, OX-40, CD137); 4. Previously received anti-angiogenic
therapy, including but not limited to anti-angiogenic monoclonal antibodies,
anti-angiogenic TKI, etc.; 5. Received systemic systemic treatment with
proprietary Chinese medicines with anti-tumor indications or immunomodulatory
drugs (including thymosin, interferon, interleukin) within 2 weeks before the
first administration; 6. An active autoimmune disease requiring systemic
treatment (e.g. with disease-modifying drugs, glucocorticoids, or
immunosuppressants) has occurred within 2 years prior to first
administration.Replacement therapies (such as thyroxine, insulin, or
physiologic glucocorticoids for adrenal or pituitary insufficiency) are not
considered systemic therapy; 7. Known allogeneic organ transplantation (except
corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
8. Known active ingredients or excipients of Sintilimab and bevacizumab in this
study, and allergic patients to chemotherapy drugs in this study; 9. Has not
fully recovered from toxicity and/or complications caused by any intervention
before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or
hair loss); 10. Known history of human immunodeficiency virus (HIV) infection
(i.e. HIV 1/2 antibody positive); 11. Other researchers did not consider it
appropriate to study enrollment
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 22, 2024
Completion date:
April 22, 2026
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06364826
