Laryngeal CancerPhase 2NCT06611137
SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
A Phase 2 study testing SBRT+Toripalimab Plus Docetaxel and Cisplatin in people with Laryngeal Cancer and Hypopharynx Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laryngeal Cancer, Hypopharynx Cancer
- What is being tested?
- SBRT+Toripalimab Plus Docetaxel and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 11 Sep 2027
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th
- age 18-70
- PS score 0-1
- normal functions to tolerate chemotherapy, immunotherapy and radiotherapy
Who cannot join
- Patients with a combination of other malignant tumours
- Individuals with contraindications to immunotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dian OuYang contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fang-Yun Xie, +8613902205880, xiefy@sysucc.org.cn
Dian OuYang, ouyd@sysucc.org.cn
About this study
This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
- Conditions
- Laryngeal Cancer, Hypopharynx Cancer
- Being tested
- SBRT+Toripalimab Plus Docetaxel and Cisplatin
- Keywords
- SBRT, immunotherapy, larynx preservation, laryngeal cancer, hypopharynx cancer
- Medical subject headings
- Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT+Toripalimab Plus Docetaxel and CisplatinCombination product
All participants will receive SBRT (18Gy/3 fractions, QOD ) to gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab (240mg) Plus Docetaxel (75mg/m2, q3w) and Cisplatin (75mg/m2, q3w) for 3 cycles. If tumor has complete or partial response at 2 weeks after the last course of neoadjuvant chemotherapy, participants will then receive intensity modulated radiotherapy (54Gy/27 fractions). If tumor is stable or progressive, participants will receive radical resection with or without postoperative intensity modulated radiotherapy when necessary.
| Study group | Role | What they receive |
|---|---|---|
| SBRT+Toripalimab Plus Docetaxel and Cisplatin | Experimental | SBRT for gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin Receives: Combination Product: SBRT+Toripalimab Plus Docetaxel and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
complete and partial response rate
Measured: two weeks after the last course of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start11 Sep 2024
- Primary completion11 Sep 2025 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611137
- Sponsor's protocol ID
- B2024-373-01
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
- ClinicalTrials.gov ID
- NCT06611137
- Acronym / sponsor ID
- B2024-373-01
- Conditions
- Laryngeal Cancer, Hypopharynx Cancer
- Keywords
- SBRT, immunotherapy, larynx preservation, laryngeal cancer, hypopharynx cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 11 Sep 2025 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to evaluate the safety and efficiency of SBRT followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT+Toripalimab Plus Docetaxel and Cisplatin | Experimental | Combination Product: SBRT+Toripalimab Plus Docetaxel and CisplatinSBRT for gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laryngeal (T3-4N0-3M0 ) and hypopharyngeal ( T2-4N0-3M0) cancers staged by AJCC8th
- age 18-70
- PS score 0-1
- normal functions to tolerate chemotherapy, immunotherapy and radiotherapy
Key exclusion criteria (2 listed)
- Patients with a combination of other malignant tumours
- Individuals with contraindications to immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT+Toripalimab Plus Docetaxel and CisplatinAll participants will receive SBRT (18Gy/3 fractions, QOD ) to gross tumor and metastatic lymph nodes, followed by neoadjuvant chemoimmunotherapy of Toripalimab (240mg) Plus Docetaxel (75mg/m2, q3w) and Cisplatin (75mg/m2, q3w) for 3 cycles. If tumor has complete or partial response at 2 weeks after the last course of neoadjuvant chemotherapy, participants will then receive intensity modulated radiotherapy (54Gy/27 fractions). If tumor is stable or progressive, participants will receive radical resection with or without postoperative intensity modulated radiotherapy when necessary. | Combination product | SBRT+Toripalimab Plus Docetaxel and Cisplatin |
Primary outcome
objective response rate
Time frame: two weeks after the last course of neoadjuvant chemotherapy
complete and partial response rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dian OuYang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT+Toripalimab Plus Docetaxel and Cisplatin in people with Laryngeal Cancer and Hypopharynx Cancer, 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Sep 2024. 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 (+8613902205880, xiefy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: two weeks after the last course of neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2024.