Trial Title:
Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC
NCT ID:
NCT06345287
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Antibodies
Conditions: Keywords:
radical radiotherapy
induction immunotherapy and chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
radical radiotherapy (60Gy)
Description:
concurrent chemoradiotherapy (60Gy) after induction therapy
Arm group label:
clinical complete response
Intervention type:
Radiation
Intervention name:
radical radiotherapy (66Gy)
Description:
concurrent chemoradiotherapy (66Gy) after induction therapy
Arm group label:
deep partial response
Intervention type:
Radiation
Intervention name:
radical radiotherapy (70Gy)
Description:
concurrent chemoradiotherapy (70Gy) after induction therapy
Arm group label:
non-deep partial response
Intervention type:
Combination Product
Intervention name:
anti-PD-1 or PD-L1 antibody
Description:
immunotherapy maintenance with anti-PD-1 or PDL1antibody every three weeks for 1 year
after radiotherapy
Arm group label:
clinical complete response
Arm group label:
deep partial response
Arm group label:
non-deep partial response
Summary:
The aim of this study is to develop an adaptive radiation therapy plan for locally
advanced head and neck squamous cell carcinoma receiving induction therapy containing
immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order
to reduce treatment-related toxic side effects without sacrificing clinical efficacy and
improve the quality of life of patients.
Detailed description:
Induction chemotherapy combined with immunotherapy has shown promising efficacy in
locally advanced head and neck cancers. However, the appropriate dose and range of the
following radical radiotherapy treatment remains unknown. Eligibility patients were
assigned to three arms depending on the degree of clinical remission: clinical complete
response (radiotherapy 60Gy + concurrent chemotherapy + immunotherapy maintenance), deep
partial response (radiotherapy 66Gy + concurrent chemotherapy + immunotherapy
maintenance, non-deep partial response (radiotherapy 70Gy + concurrent chemotherapy +
immunotherapy maintenance). Progression-free survival, overall survival, and
treatment-related toxicity would be calculated to evaluate the efficacy of treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Head and neck squamous cell carcinoma patients who undergo 2-4 cycles of induction
chemotherapy and immunotherapy and plan to undergo radical radiotherapy treatment (
after MDT evaluation and communication with the patient, surgery is not recommended
to preserve organ function, or the patient refuses surgery );
2. Age range from 18 to 75 years old;
3. Squamous cell carcinoma of the head and neck confirmed by pathological tissue
biopsy;
4. Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition);
5. HPV or P16 (-);
6. ECOG score 0-1 points;
7. No contraindications to immunotherapy and radiotherapy;
8. The functional level of the main organs meets the following standards:1) The blood
routine examination standards need to meet: WBC ≥ 3.0 × 109/L, ANC ≥ 2.0 × 109/L,
PLT ≥ 100 × 109/L, HGB ≥ 90g/L (no blood transfusion or blood products within 14
days, no use of G-CSF or other hematopoietic stimulating factors correction);2)
Biochemical examination must meet the following standards: TBIL ≤ 2.0 × ULN, ALT,
AST ≤ 2.5 × ULN, BUN and CRE ≤ 1.5 × ULN, or endogenous creatinine clearance rate ≥
60ml/min (Cockcroft Gout formula);3) Good coagulation function: defined as
international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; If
the subject is receiving anticoagulant treatment, as long as the PT is within the
intended range of use of the anticoagulant drug;4) The myocardial enzyme spectrum is
within the normal range;
9. Women of childbearing age must have taken reliable contraceptive measures, or have
undergone pregnancy tests (serum or urine) within 7 days before enrollment, and the
results are negative. They must be willing to use effective methods of contraception
during the treatment period and within 2 months thereafter. For male participants
whose partners are women of childbearing age, effective methods of contraception
should be used during and within 2 months after treatment;
10. Voluntarily participate in this study, sign an informed consent form, have good
compliance, and cooperate with follow-up.
Exclusion Criteria:
1. Previous or concurrent incurable malignant tumors in other parts, except cured skin
basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma and
superficial bladder cancer;
2. Suffering from any active autoimmune disease or having a history of autoimmune
diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary
inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism
(can be included after normal hormone replacement therapy); Asthma patients who
suffer from vitiligo or have completely relieved childhood asthma and do not require
any intervention in adulthood can be included, while asthma patients who require
medical intervention with bronchodilators cannot be included;
3. Suffering from uncontrolled cardiovascular diseases: Grade II or above myocardial
ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc
interval ≥ 470 ms); According to NYHA standards, patients with grade III-IV cardiac
dysfunction or those with left ventricular ejection fraction (LVEF)<50% indicated by
echocardiography; Have experienced myocardial infarction within one year;
4. Active infection or unexplained fever exceeding 38.5 ℃ during screening or before
first administration (according to the researcher's judgment, subjects with fever
caused by tumors can be included in the study);
5. People with congenital or acquired immune deficiency (such as HIV infected people),
active hepatitis B (HBV-DNA ≥ 104 copies/ml) or hepatitis C (hepatitis C antibody is
positive, and HCR-RNA is higher than the detection limit of the analytical method);
6. Previously received other PD-1 antibody treatments or other immunotherapies
targeting PD-1/PD-L1;
7. Known to be allergic to cisplatin, macromolecular protein preparations, or any anti
PD-1 antibody component;
8. If the subject undergoes major surgery without tumor treatment, the toxic reactions
and/or complications caused by the surgical intervention must be fully recovered
before starting treatment;
9. Pregnant or lactating women;
10. In the investigator's judgment, the subjects had other factors that might have led
to their forced discontinuation of the study, such as other serious medical
conditions (including mental illness) requiring concomitant treatment, serious
abnormalities in laboratory test values, or family or social factors that might have
affected the safety of the subjects or the circumstances of the trial data
collection.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingbo Wang, Doctor
Phone:
15811166516
Email:
wangjingbo303@yahoo.com
Start date:
January 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345287
