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Oral Squamous Cell Carcinoma (OSCC)Phase 2NCT06861712

Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer

A Phase 2 study testing SBRT, Docetaxel, Cisplatin, Toripalimab and Radical resection surgery in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy*3 fractions) to treat the primary tumor and metastatic lymph nodes. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
SBRT, Docetaxel, Cisplatin, Toripalimab and Radical resection surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
6 May 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Oral/oropharyngeal squamous cell carcinoma confirmed by histology and/or cytology.
  • Clinical stage: resectable oral/oropharyngeal squamous cell carcinoma stage III-IVa (AJCC 8th edition)
  • Age: 18-65 years old.
  • According to the Eastern Cooperative Oncology Group (ECOG) criteria (performance status score of 0 or 1).
  • Good organ function:
  • Hematology: WBC ≥ 4000/μL, neutrophil ≥ 2.000/μL, hemoglobin ≥ 9g/dL, platelet ≥ 100000/μL; B. Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert's disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times, and alkaline phosphatase ≤ 3 times ULN; albumin ≥ 3g/dL; C. International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times; D. Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60mL/min according to the Cockcroft-Gault formula.
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  • Expected survival ≥ 3 months.
  • The patient has signed an informed consent form and is willing and able to comply with the study visits, treatment plans, laboratory tests and other study procedures.
  • Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose (including chemotherapy drugs and Teplizumab).
  • If the female partner of the male subject is still of childbearing potential, the male subject must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose.

Who cannot join

  • Patients with other malignant tumors.
  • Patients with known or suspected autoimmune diseases, including dementia and epilepsy.
  • Patients with severe mental illness.
  • Patients with necrotic lesions and who are assessed by the researchers to be at risk of major bleeding.
  • Patients with severe heart disease, pulmonary dysfunction, heart function and pulmonary function below grade 3 (including grade 3).
  • Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment.
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  • Patients who have received systemic or local glucocorticoid treatment within 4 weeks before enrollment.
  • Patients with complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects.
  • Patients with active pulmonary tuberculosis (TB) who are currently receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening.
  • Previous use of anti-toripalimab, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway).
  • Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or complete remission of asthma in childhood and no need for any intervention as adults can be included; patients with asthma requiring medical intervention with bronchodilators cannot be included).
  • HIV positive.
  • HBsAg positive and HBVDNA copy number positive (quantitative detection ≥1000cps/ml); positive blood screening for chronic hepatitis C (HCV antibody positive).
  • Any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) received within 4 weeks before enrollment.
  • Women of childbearing age with positive pregnancy test and breastfeeding women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fang-Yun Xie, Principal Investigator contact

86+020-87342925

xiefy@sysucc.org.cn

China1 site

  • Department of Radiation Oncology, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

    Fang-Yun Xie, Principal Investigator, 86+020-87342926, xiefy@sysucc.org.cn

Other trials in China

About this study

Official title: Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial

In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.

Read the detailed description

Participants will be randomly assigned to the experimental group and the control group. The experimental group will first receive SBRT (Stereotactic Body Radiotherapy) for the primary tumor and positive lymph nodes (prescribed dose: 6 Gy × 3 fractions, once every other day). One to two weeks after SBRT, they will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. The control group will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. Both groups will undergo imaging assessment 2 weeks after the final chemotherapy cycle. Three weeks after the last chemotherapy cycle, participants will receive curative surgery. Postoperative adjuvant radiotherapy ± chemotherapy will be administered according to preoperative staging and postoperative pathological characteristics. Patients may also choose to continue maintenance treatment with Toripalimab after surgery.

Being tested
SBRT, Docetaxel, Cisplatin, Toripalimab, Radical resection surgery, IMRT ± chemotherapy/toripalimab
Keywords
Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC), Stereotactic Body Radiation Therapy (SBRT), Toripalimab, Phase II Clinical Trial
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    The experimental group will first receive SBRT (Stereotactic Body Radiotherapy) for the primary tumor and positive lymph nodes (prescribed dose: 6 Gy × 3 fractions, once every other day).

  • Docetaxel, Cisplatin, ToripalimabDrug

    Also called Neoadjuvant Chemoimmunotherapy

    Toripalimab 240mg (free medicine) + Docetaxel 75mg/m2 + Cisplatin 75mg/m2, q3w for 3 courses

  • Radical resection surgeryProcedure or surgery

    Radical resection surgery

  • IMRT ± chemotherapy/toripalimabRadiation

    According to the preoperative staging and postoperative pathological characteristics, all patients will receive postoperative radiotherapy with or without cisplatin-based chemotherapy. Additionally, patients can choose whether to continue maintenance therapy with toripalimab after surgery.

Study groups in NCT06861712
Study groupRoleWhat they receive
Experimental GroupExperimentalThe experimental group will first receive SBRT (Stereotactic Body Radiotherapy) for the primary tumor and positive lymph nodes (prescribed dose: 6 Gy × 3 fractions, once every other day). One to two weeks after SBRT, they will receive 240 mg of Toripalimab (provided) + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles.
Receives: Radiation: SBRT; Drug: Docetaxel, Cisplatin, Toripalimab; Procedure: Radical resection surgery; Radiation: IMRT ± chemotherapy/toripalimab
Control GroupActive comparatorThe control group will directly receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles.
Receives: Drug: Docetaxel, Cisplatin, Toripalimab; Procedure: Radical resection surgery; Radiation: IMRT ± chemotherapy/toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR)

    pathological complete response rate after radical resection

    Measured: 2 weeks after the surgery

Secondary outcomes (6)

  1. Major Pathological Response (MPR)

    The proportion of patients whose microscopic tumor cells were reduced to less than 10% as assessed by the American Joint Committee on Cancer/College of American Pathologists (AJCC/CAP) tumor regression grade (TRG) scheme for surgical specimens.

    Measured: 2 weeks after the surgery

  2. Objective response rate (ORR)

    The proportion of patients with a 30% reduction in tumor volume is the sum of the complete response (CR) and partial response (PR) rates.

    Measured: two weeks after the chemoimmunotherapy

  3. Disease-free survival (DFS):

    The interval from the start of treatment to the earliest treatment failure due to any reason (including local recurrence, regional recurrence, distant metastasis, or death).

    Measured: 2 years

  4. Overall survival (OS)

    the time interval from the start of treatment to death from any cause.

    Measured: 2 years

  5. Mandibular preservation rate:

    the proportion of patients with oral cancer whose mandibular continuity is preserved after primary lesion surgery.

    Measured: immediately after the surgery

  6. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    the proportion of patients with adverse events of grade 3 or above among all patients.

    Measured: one month after the postoperative radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start6 May 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06861712
Sponsor's protocol ID
B2024-858-01
Status last verified
Apr 2025
First submitted
24 Feb 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) might not be shared due to concerns about patient privacy, ethical considerations, or institutional policies. Restrictions may also arise from data protection regulations, confidentiality agreements, or the potential risk of re-identification. Additionally, if the data includes sensitive medical information, sharing may require special approvals or de-identification processes that are not feasible.

Publications

  • Caudell JJ, Gillison ML, Maghami E, Spencer S, Pfister DG, Adkins D, Birkeland AC, Brizel DM, Busse PM, Cmelak AJ, Colevas AD, Eisele DW, Galloway T, Geiger JL, Haddad RI, Hicks WL, Hitchcock YJ, Jimeno A, Leizman D, Mell LK, Mittal BB, Pinto HA, Rocco JW, Rodriguez CP, Savvides PS, Schwartz D, Shah JP, Sher D, St John M, Weber RS, Weinstein G, Worden F, Yang Bruce J, Yom SS, Zhen W, Burns JL, Darlow SD. NCCN Guidelines(R) Insights: Head and Neck Cancers, Version 1.2022. J Natl Compr Canc Netw. 2022 Mar;20(3):224-234. doi: 10.6004/jnccn.2022.0016.

    PubMed 35276673

  • Harrington KJ, Burtness B, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Brana I, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2023 Feb 1;41(4):790-802. doi: 10.1200/JCO.21.02508. Epub 2022 Oct 11.

    PubMed 36219809

  • Noronha V, Goswami C, Patil S, Joshi A, Patil VM, Murthy V, Arya S, Juvekar S, Goud S, Prabhash K. Response to docetaxel and cisplatin induction chemotherapy of locally advanced head and neck squamous cell carcinoma: a multicenter, non-comparative, open-label interventional pilot study. J Laryngol Otol. 2016 Sep;130(9):833-42. doi: 10.1017/S0022215116008513. Epub 2016 Jul 26.

    PubMed 27456399

  • Herman LC, Chen L, Garnett A, Feldman LE, Smith B, Weichselbaum RR, Spiotto MT. Comparison of carboplatin-paclitaxel to docetaxel-cisplatin-5-flurouracil induction chemotherapy followed by concurrent chemoradiation for locally advanced head and neck cancer. Oral Oncol. 2014 Jan;50(1):52-8. doi: 10.1016/j.oraloncology.2013.08.007. Epub 2013 Sep 19.

    PubMed 24055193

  • Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. doi: 10.1200/JCO.2012.43.6097. Epub 2012 Nov 26.

    PubMed 23182993

  • Choi YJ, Chung J, Shin HJ, Cho GJ, Wang SG, Lee BJ, Cho BM, Kim DW, Kim HJ, Lee WS, Joo YD, Sohn CH. Induction chemotherapy of docetaxel and Cisplatin for the elderly patients with squamous cell carcinoma of the head and neck. Cancer Res Treat. 2007 Mar;39(1):1-5. doi: 10.4143/crt.2007.39.1.1. Epub 2007 Mar 31.

    PubMed 19746234

  • Lorch JH, Goloubeva O, Haddad RI, Cullen K, Sarlis N, Tishler R, Tan M, Fasciano J, Sammartino DE, Posner MR; TAX 324 Study Group. Induction chemotherapy with cisplatin and fluorouracil alone or in combination with docetaxel in locally advanced squamous-cell cancer of the head and neck: long-term results of the TAX 324 randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):153-9. doi: 10.1016/S1470-2045(10)70279-5. Epub 2011 Jan 11.

    PubMed 21233014

  • Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; EORTC 24971/TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. doi: 10.1056/NEJMoa071028.

    PubMed 17960012

  • Chow LQM. Head and Neck Cancer. N Engl J Med. 2020 Jan 2;382(1):60-72. doi: 10.1056/NEJMra1715715. No abstract available.

    PubMed 31893516

  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

    PubMed 36633525

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT, Docetaxel, Cisplatin, Toripalimab and Radical resection surgery in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fang-Yun Xie, Principal Investigator (86+020-87342925, xiefy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) (time frame: 2 weeks after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06861712, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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