Actively Recruiting
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-05-08
140
Participants Needed
1
Research Sites
507 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Two randomized trials of reirradiation after salvage surgery have been conducted by the GETTEC and GORTEC collaborative groups, both members of the French HN Intergroup: The first trial compared reirradiation and a "wait and see attitude" and was published in 2008 \[1\]. The second trial compared two modalities of reirradiation. Our hypothesis is that adjuvant treatment with immunotherapy will lead to a DFS similar to that observed in previous trials of post-operative reirradiation with possibly lower toxicity.
CONDITIONS
Official Title
Adjuvant Immunotherapy After Salvage Surgery in Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrence or second primary of HNSCC in a previously irradiated area at a dose 3 50 Gys
- HNSCC of oral cavity, oro and hypopharynx, larynx only if extralaryngeal spread (rT4), isolated nodal recurrence
- Salvage surgery with curative intent and complete macroscopic resection
- For cohorts 1 and 2: more than 6 months between radiotherapy and salvage surgery
- For cohorts 1bis and 2bis: less than 6 months between radiotherapy and salvage surgery
- Recurrence with poor prognosis requiring adjuvant treatment (clinically infiltrative recurrence or second primary; nodal recurrence 3 cm; association of local and nodal recurrence; or histologic signs of high risk)
- Sufficient healing to start adjuvant treatment within 8 weeks (�b1 2 weeks) after salvage surgery
- No distant metastases confirmed by CT or PET scan
- Male and female between 18 and 75 years old
- ECOG performance status of 0 or 1
- Immunosuppressive systemic medications (e.g., steroids > 10 mg/day prednisone) discontinued at least 2 weeks before study drug
- Laboratory values within required limits obtained within 14 days before first treatment
- Negative pregnancy test within 24 hours before first treatment for women of childbearing potential
- Agreement to use effective contraception or abstain from sexual activity during study and for months after treatment
- Breastfeeding women must discontinue nursing before first dose and during treatment period
- Ability to understand, sign informed consent, and comply with study visits
- Affiliated to a social security system or equivalent
You will not qualify if you...
- Recurrent or metastatic carcinoma of the nasopharynx, skin or salivary gland squamous cell carcinoma, or nonsquamous histologies
- Recurrence or second primary in a non-irradiated area or previously irradiated with dose < 50 Gys
- Macroscopic incomplete surgery (no debulking allowed)
- Superficial recurrence without nodal involvement and no high-risk histologic signs
- Nodal recurrence less than 3 cm without local recurrence and no capsular rupture
- Severe cardiac, lung, or liver dysfunction
- Active or suspected autoimmune disease requiring systemic treatment (exceptions apply)
- Systemic corticosteroids or immunosuppressants within 14 days before study drug
- Active hepatitis B or C infection
- HIV infection or AIDS
- Prior malignancy within 3 years except certain locally curable cancers
- Prior treatment with immune checkpoint inhibitors
- Ongoing anti-cancer therapies within 4 weeks before study drug
- Use of live virus vaccines within 4 weeks before study drug
- Medical conditions that increase risk or interfere with treatment evaluation
- Therapeutic anticoagulant use (low dose allowed for prevention)
- History of autoimmune inflammatory diseases
- Active serious infections requiring systemic therapy
- History of severe allergic reaction to monoclonal antibodies or study drugs
- Pregnancy or breastfeeding
- Psychological, social, or familial factors interfering with consent or follow-up
- Previous allogenic stem cell or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, Val De Marne, France, 94805
Actively Recruiting
Research Team
A
Alix MARHIC, MD
CONTACT
E
Elodie LECERF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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