Larynx CancerPhase 2NCT06039631
Neoadjuvant Chemoimmunotherapy Followed By Radiation Or Organ Preservation Surgery In Laryngeal/Hypopharyngeal Cancer
A Phase 2 study testing Surgery, Radiation and Toripalimab in people with Larynx Cancer and Hypopharyngeal Cancer, run by Fudan University at 1 site in China.
Trial summary
In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Larynx Cancer, Hypopharyngeal Cancer
- What is being tested?
- Surgery, Radiation and Toripalimab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2023to 1 Sep 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the informed consent form and willingness to comply with the study protocol.
- Age ≥18 and ≤75 years.
- Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.
- Locally advanced laryngeal/hypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).
- Presence of at least one measurable lesion before treatment, in accordance with RECIST 1.1 criteria for "measurable lesions."
- Patients who have received neoadjuvant immunotherapy combined with chemotherapy and have achieved a partial response (PR) in the primary lesion according to RECIST 1.1 criteria and are suitable candidates for organ preservation surgery.
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- Expected survival of more than 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Good organ function, meeting the following criteria:
- Absolute neutrophil count (ANC) ≥1.5×10^9/L.
- Platelet count ≥100×10^9/L.
- Hemoglobin ≥9 g/dL.
- Serum albumin ≥2.8 g/dL.
- Total bilirubin ≤1.5× upper limit of normal (ULN), ALT, AST, and/or ALP ≤3× ULN.
- Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula, see Appendix III).
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5× ULN (patients on stable doses of anticoagulation with agents like low molecular weight heparin or warfarin, and INR within the expected therapeutic range, may be included).
- Patients with hepatitis B virus (HBV) infection, inactive/asymptomatic HBV carriers, or patients with chronic or active HBV infection with HBV DNA <500 IU/mL (or 2500 copies/mL) at screening will be allowed to participate. Patients positive for hepatitis C antibodies, if HCV-RNA is negative at screening, will be allowed to participate.
- Females of childbearing potential must have a negative pregnancy test result in urine or serum ≤7 days before treatment initiation. They must use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.
- Non-sterilized male participants must be willing to use a medically accepted contraceptive measure (such as intrauterine device, oral contraceptives, or condoms) during the study treatment period, for at least 3 months after the last dose of toripalimab, and for at least 6 months after the last dose of chemotherapy.
Who cannot join
- History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.
- Pre-existing tracheostomy due to laryngeal dysfunction before treatment.
- History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.
- Uncontrolled clinical cardiac symptoms or diseases, including:
- NYHA Class II or higher heart failure.
- Unstable angina.
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- Myocardial infarction within the past year.
- Clinically significant ventricular or supraventricular arrhythmias requiring clinical intervention.
- Previous treatment with any of the following:
- Use of any investigational drug within 4 weeks prior to the first dose of study treatment.
- Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial.
- Requiring systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of study treatment, excluding corticosteroids for localized inflammation or prophylaxis against allergies or nausea/vomiting. Other specific circumstances should be discussed with the investigator. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with a dose of >10 mg/day prednisone or equivalent are allowed.
- Vaccination with anti-tumor vaccines or administration of live vaccines within 4 weeks prior to the first dose of study treatment (for patients who received COVID-19 vaccine, a 2-week interval is required).
- Major surgery within 4 weeks before the first dose of study treatment or presence of severe trauma.
- Failure to recover to ≤ Grade 1 toxicity per CTCAE (except for alopecia and residual neuropathy related to prior platinum therapy) from previous cancer therapy or from any other cause unrelated to study/enrollment criteria.
- Experience of severe infections (CTCAE > Grade 2) within 4 weeks before the first dose of study treatment, such as severe pneumonia requiring hospitalization, sepsis, or complicated infections. Baseline chest imaging indicating active pulmonary inflammation, presence of symptoms and signs of infection within 4 weeks before the first dose of study treatment, or requirement for oral or intravenous antibiotics to treat infection are exclusion criteria.
- Active autoimmune disease or history of autoimmune disease, such as interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes. However, stable dose of thyroid replacement therapy for autoimmune-mediated hypothyroidism is allowed. Stable dose of insulin for type I diabetes is allowed. Patients with vitiligo or childhood-onset asthma/allergies requiring no intervention as adults are allowed.
- History of immune deficiency, including HIV positive test results, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- History of interstitial lung disease (excluding radiation pneumonitis not treated with steroids), non-infectious pneumonitis.
- Active tuberculosis infection found through medical history or CT scan, or presence of active tuberculosis infection within the past year prior to enrollment, or history of active tuberculosis infection more than 1 year ago but not formally treated.
- Presence of active hepatitis B (HBV DNA ≥500 IU/mL or 2500 copies/mL) or hepatitis C (HCV-RNA positive with HCV-RNA levels above the lower limit of detection of the assay) infection＊.
- Known history of substance abuse, alcohol abuse, or drug addiction.
- Pregnant or breastfeeding women.
- Other factors, as judged by the investigator, that may interfere with the participant's ability to comply with the study requirements or that may jeopardize the safety of the participant or the quality of the study data, including the presence of other severe diseases (including mental illness) requiring concurrent treatment, severe abnormal laboratory values, family or social factors, which might affect participant safety or data collection.
- For participants who are HBsAg-positive and either HBV DNA-negative or with HBV DNA <500 IU/mL or 2500 copies/mL, after receiving stable antiviral treatment, they may be included in this trial (treatment should be ongoing for >2 weeks before enrollment, and continued for 6 months after the last dose of study treatment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yu Wang, M.D., +8618017313971, neck130@hotmail.com
Xiaomin Ou, M.D., +8618017317872, 0456218@fudan.edu.cn
About this study
Official title: Neoadjuvant Immunotherapy And Chemotherapy Followed By Concurrent Chemoradiation Or Organ Preservation Surgery In Locally Advanced Laryngeal Cancer And Hypopharyngeal Cancer
In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.
Past approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.
Against this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.
Read the detailed description
Head and neck cancer stands as one of the most prevalent forms of malignancy on a global scale. Among these, head and neck squamous cell carcinoma (HNSCC) takes precedence as the predominant histological subtype, encompassing around 90% of the total caseload. Notably, laryngeal and hypopharyngeal cancer contribute to approximately 30% of these instances. Upon initial diagnosis, a striking majority-over 50% of patients find themselves grappling with locally advanced disease, necessitating an assertive therapeutic approach that significantly impacts their overall quality of life. Despite the rigor of these treatments, the prognosis for laryngeal and hypopharyngeal cancer remains discouraging, characterized by a 5-year overall survival rate ranging between 30% and 50%.
Past endeavors have been dedicated to preserving laryngeal function and enhancing the well-being of patients, spanning from the adoption of minimally invasive and organ-conserving surgical techniques to advancements in radiotherapy and the advent of induction chemotherapy. Recent strides in immunotherapy, particularly the integration of programmed cell death protein-1 (PD-1) inhibitors, have brought about a remarkable paradigm shift in how recurrent/metastatic HNSCC is managed. Our previous investigation underscored the efficacy of the strategy involving the combination of toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgical intervention, showcasing favorable short-term outcomes and manageable adverse effects. The data further revealed highly promising larynx preservation rates at the one-year mark.
Given this backdrop, the present study seeks to delve into patients experiencing partial relief through neoadjuvant immunotherapy combined with chemotherapy in cases of locally advanced laryngeal and hypopharyngeal cancer. The study aims to compare the therapeutic efficacy and discrepancies in quality of life resulting from concurrent radiochemotherapy and organ-preserving surgical treatment. The overarching goal is to delineate optimal strategies for subsequent interventions.
- Conditions
- Larynx Cancer, Hypopharyngeal Cancer
- Being tested
- Surgery, Radiation, Toripalimab
- Keywords
- organ preservation, PD-1 inhibitor, Immunotherapy, Neoadjuvant chemotherapy, Induction chemotherapy, larynx presrvation surgery
- 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.
SurgeryProcedure or surgery
In the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended.
RadiationRadiation
In the surgical group, depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended.
In the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin at a dosage of 30 mg/m².
ToripalimabDrug
In the both groups, starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Organ preservation surgery | Experimental | In the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended, and the specific surgical approach will be chosen based on individual case characteristics and the treatment protocols followed at our center. Depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended. Starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles. Receives: Procedure: Surgery; Radiation: Radiation; Drug: Toripalimab |
| Concurrent chemoradiation | Other | In the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin. Starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles. Receives: Radiation: Radiation; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
Progression-free survival is defined as the time interval from the commencement of randomization until the first documented occurrence of objective tumor progression or death due to any cause, whichever comes first.
Measured: At two year post-randomization
Secondary outcomes (4)
Larynx Preservation rate
Larynx-preservation is considered to have failed on the date of total laryngectomy, or evidence of local recurrence on primary site.
Measured: At two year post-randomization
Overall Survival rate
Overall survival is measured as the time from the initiation of randomization to the occurrence of death due to any cause.
Measured: At two year post-randomization
Quality of life
Evaluated by MD Anderson Dysphagia Inventory, Voice Handicap Index 10
Measured: From enrollment to two year post-randomization
Adverse events
Adverse events evaluated by CTCAE 5.0 criteria
Measured: From enrollment to two year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start22 Aug 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the selection trial design
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University Eye Ear Nose and Throat Hospital, Shanghai Zhongshan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039631
- Sponsor's protocol ID
- Larynx-IO 2.0
- Status last verified
- Sep 2023
- First submitted
- 9 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sharing of inviduual participant data will be decided after the pubilcation of this research and the approvement of IRB of Fudan Univerisity Shanghai Cancer Center
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy And Chemotherapy Followed By Concurrent Chemoradiation Or Organ Preservation Surgery In Locally Advanced Laryngeal Cancer And Hypopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT06039631
- Acronym / sponsor ID
- Larynx-IO 2.0
- Conditions
- Larynx Cancer, Hypopharyngeal Cancer
- Keywords
- organ preservation, PD-1 inhibitor, Immunotherapy, Neoadjuvant chemotherapy, Induction chemotherapy, larynx presrvation surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fudan University Eye Ear Nose and Throat Hospital, Shanghai Zhongshan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 15 Sep 2023 (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.
In the global landscape of cancer, head and neck malignancies are highly prevalent, with 878,000 new cases and 444,000 deaths recorded in 2020. Notably, laryngeal and hypopharyngeal cancers contribute to around 30% of these instances. More than 50% of patients are diagnosed with locally advanced disease, necessitating intensive treatments that significantly impact their quality of life. Despite these efforts, the prognosis for laryngeal and hypopharyngeal cancers remains grim, with a 5-year survival rate of 30% to 50%.
Past approaches focused on preserving laryngeal function and patient well-being, including minimally invasive surgery, advanced radiotherapy, and induction chemotherapy. Our prior research highlighted the effectiveness of combining toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgery. Positive short-term outcomes and manageable side effects were observed, with encouraging larynx preservation rates after one year.
Against this backdrop, the current study aims to explore neoadjuvant immunotherapy combined with chemotherapy for patients with locally advanced laryngeal and hypopharyngeal cancer. It seeks to compare the therapeutic efficacy and quality of life impacts of concurrent radiochemotherapy and organ-preserving surgery. The ultimate goal is to identify optimal strategies for future interventions.
Detailed description
Head and neck cancer stands as one of the most prevalent forms of malignancy on a global scale. Among these, head and neck squamous cell carcinoma (HNSCC) takes precedence as the predominant histological subtype, encompassing around 90% of the total caseload. Notably, laryngeal and hypopharyngeal cancer contribute to approximately 30% of these instances. Upon initial diagnosis, a striking majority-over 50% of patients find themselves grappling with locally advanced disease, necessitating an assertive therapeutic approach that significantly impacts their overall quality of life. Despite the rigor of these treatments, the prognosis for laryngeal and hypopharyngeal cancer remains discouraging, characterized by a 5-year overall survival rate ranging between 30% and 50%.
Past endeavors have been dedicated to preserving laryngeal function and enhancing the well-being of patients, spanning from the adoption of minimally invasive and organ-conserving surgical techniques to advancements in radiotherapy and the advent of induction chemotherapy. Recent strides in immunotherapy, particularly the integration of programmed cell death protein-1 (PD-1) inhibitors, have brought about a remarkable paradigm shift in how recurrent/metastatic HNSCC is managed. Our previous investigation underscored the efficacy of the strategy involving the combination of toripalimab-based induction therapy and chemotherapy, followed by concurrent chemoradiotherapy or surgical intervention, showcasing favorable short-term outcomes and manageable adverse effects. The data further revealed highly promising larynx preservation rates at the one-year mark.
Given this backdrop, the present study seeks to delve into patients experiencing partial relief through neoadjuvant immunotherapy combined with chemotherapy in cases of locally advanced laryngeal and hypopharyngeal cancer. The study aims to compare the therapeutic efficacy and discrepancies in quality of life resulting from concurrent radiochemotherapy and organ-preserving surgical treatment. The overarching goal is to delineate optimal strategies for subsequent interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the selection trial design
| Arm | Type | Receives |
|---|---|---|
| Organ preservation surgery | Experimental | Procedure: Surgery, Radiation: Radiation, Drug: ToripalimabIn the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended, and the specific surgical approach will be chosen based on individual case characteristics and the treatment protocols followed at our center. Depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended. Starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles. |
| Concurrent chemoradiation | Other | Radiation: Radiation, Drug: ToripalimabIn the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin. Starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Signing of the informed consent form and willingness to comply with the study protocol.
- Age ≥18 and ≤75 years.
- Histologically confirmed laryngeal or hypopharyngeal squamous cell carcinoma.
- Locally advanced laryngeal/hypopharyngeal cancer patients eligible for surgical resection (AJCC 8th edition stage: T2N+M0, T3-T4aN0-3M0).
- Presence of at least one measurable lesion before treatment, in accordance with RECIST 1.1 criteria for "measurable lesions."
Key exclusion criteria (25 listed)
- History of allergic reactions to any components of toripalimab, paclitaxel, or cisplatin.
- Pre-existing tracheostomy due to laryngeal dysfunction before treatment.
- History of or concurrent presence of other malignancies (except for those cured and with no cancer-related survival exceeding 5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer). Patients with concurrent hypopharyngeal and esophageal cancers, where the lesions are not anatomically adjacent, will be diagnosed as having dual primary tumors and will not be eligible for inclusion.
- Uncontrolled clinical cardiac symptoms or diseases, including:
- Previous treatment with any of the following:
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 |
|---|---|---|
| SurgeryIn the surgical group, patients will undergo curative surgery for laryngeal/hypopharyngeal cancer along with cervical lymph node dissection. Organ preservation surgery is recommended. | Procedure or surgery | Organ preservation surgery |
| RadiationIn the surgical group, depending on postoperative pathology results, adjuvant radiotherapy or concurrent radiochemotherapy may be administered as deemed necessary. If postoperative pathology indicates extracapsular invasion of lymph nodes or positive surgical margins, concurrent radiochemotherapy based on cisplatin is recommended. In the concurrent radiochemotherapy group, patients will undergo target delineation based on the scope before induction chemotherapy. Radiotherapy will be administered at a total dose of 70 Gy over 35 fractions, and concurrent chemotherapy will involve weekly administration of cisplatin at a dosage of 30 mg/m². | Radiation | Concurrent chemoradiation, Organ preservation surgery |
| ToripalimabIn the both groups, starting three weeks after the completion of radiotherapy, patients will receive adjuvant immunotherapy using a specific protocol of toripalimab at a dose of 240 mg every 3 weeks for a total of 8 cycles. | Drug | Concurrent chemoradiation, Organ preservation surgery |
Primary outcome
Progression-free survival rate
Time frame: At two year post-randomization
Progression-free survival is defined as the time interval from the commencement of randomization until the first documented occurrence of objective tumor progression or death due to any cause, whichever comes first.
4 secondary outcomes
Larynx Preservation rate
Time frame: At two year post-randomization
Overall Survival rate
Time frame: At two year post-randomization
Quality of life
Time frame: From enrollment to two year post-randomization
Adverse events
Time frame: From enrollment to two year post-randomization
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 15 Sep 2023.
- Individual participant dataSharing planned: Yes. The sharing of inviduual participant data will be decided after the pubilcation of this research and the approvement of IRB of Fudan Univerisity Shanghai Cancer Center
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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.
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 Surgery, Radiation and Toripalimab in people with Larynx Cancer and Hypopharyngeal Cancer, run by Fudan 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 19 inclusion and 25 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 15 Sep 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (time frame: At two year post-randomization). 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 15 Sep 2023.