Head and Neck CancerPhase 1/2NCT06494943
Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC
A Phase 1/2 study testing Sintilimab, IBI110 and Paclitaxel in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Sintilimab, IBI110 and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 31 Dec 2028
- Phase
- Phase 1/2
- 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
- Signed informed consent and willing to complete the study as per the protocol;
- Age ≥ 18 years and ≤ 75 years;
- Histologically confirmed head and neck squamous cell carcinoma, including primary sites in the oropharynx, oral cavity, larynx, and hypopharynx;
- Resectable locally advanced head and neck squamous cell carcinoma (AJCC 8th edition: Stage III-IVB);
- At least one measurable lesion before treatment, meeting the RECIST 1.1 criteria for "measurable disease";
- Expected survival > 3 months;
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- ECOG performance status 0-1;
- Adequate 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 × ULN, ALT, AST, and/or ALP ≤ 3 × ULN;
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL/min (Cockcroft-Gault, see Appendix III);
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulants such as low-molecular-weight heparin or warfarin with INR within the therapeutic range may be screened);
- Patients with HBV infection and inactive/asymptomatic HBV carriers, or those with chronic or active HBV, may be enrolled if HBV DNA < 500 IU/mL (or 2500 copies/mL) at screening. Patients with positive HCV antibodies may be enrolled if HCV-RNA is negative at screening;
- Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before treatment and use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose of sintilimab and 6 months after the last dose of chemotherapy;
- Non-sterilized male participants must agree to use medically accepted contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 3 months after the last dose of toripalimab and 6 months after the last dose of chemotherapy.
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- History of or concurrent other malignancies (excluding those that have been cured with a cancer-free survival period of more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma);
- Receipt of any of the following treatments:
- Any investigational drug within 4 weeks prior to the first use of the study drug;
- Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study;
- Systemic treatment with corticosteroids (daily dose >10 mg prednisone equivalent) or other immunosuppressive drugs within 2 weeks before the first use of the study drug, except for corticosteroids used for local inflammation and prevention of allergies, nausea, and vomiting. Special cases need to be discussed with the investigator. Inhaled or topical steroids and adrenal corticosteroid replacement therapy with doses >10 mg/day prednisone equivalent are allowed in the absence of active autoimmune disease;
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- Anti-tumor vaccination or live vaccination within 4 weeks prior to the first administration of the study drug (for COVID-19 vaccination, the interval between vaccination and treatment should be more than 2 weeks);
- Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
- Uncontrolled cardiac clinical symptoms or diseases, such as:
- Heart failure of NYHA class II or higher;
- Unstable angina;
- Myocardial infarction within 1 year;
- Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infections (CTCAE > Grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complications of infections. Baseline chest imaging indicating active pulmonary inflammation, symptoms and signs of infection within 4 weeks prior to the first use of the study drug, or requiring oral or intravenous antibiotics;
- Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except for autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, type 1 diabetes with a stable dose of insulin, vitiligo, or childhood asthma/allergies that have resolved without intervention in adulthood;
- History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation;
- History of interstitial lung disease (excluding radiation pneumonitis that did not require steroid treatment) or non-infectious pneumonia;
- Active pulmonary tuberculosis infection identified by history or CT scan, or a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment;
- Participants with active hepatitis B (HBV DNA ≥500 IU/mL or 2500 copies/mL) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection by the assay);
- Known history of psychiatric drug abuse, alcoholism, or drug addiction;
- Pregnant or breastfeeding women;
- Other factors deemed by the investigator that could lead to forced early termination of the study, such as severe concomitant disease (including mental illness) requiring combined treatment, severely abnormal laboratory test values, or family or social factors that may affect the safety of the participant or the collection of trial data.
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 IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial
This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Read the detailed description
The NCCN guidelines recommend that for resectable locally advanced HNSCC, the recommended treatment include surgery combined with postoperative adjuvant radiotherapy (chemoradiotherapy), or concurrent chemoradiotherapy; for locally extensive HNSCC, the guidelines recommend considering neoadjuvant chemotherapy, with subsequent selection of surgery or chemoradiotherapy based on the efficacy of the neoadjuvant chemotherapy. In recent years, multiple studies have shown that combining PD-1 inhibitors with neoadjuvant chemotherapy may help improve the pathological response rate of surgical resection.
LAG-3 (Lymphocyte Activation Gene 3) is a cell surface molecule co-expressed with CD4 and CD8 on activated CD4+ and CD8+ T cells, natural killer (NK) cells, B cells, and dendritic cells. LAG-3 is an activation-induced T cell receptor (TCR) co-receptor with high affinity for major histocompatibility complex (MHC) class II molecules, and it can directly inhibit TCR signal transduction in the immune response through its interaction with MHC II.
IBI110 can directly bind to LAG-3 on T cells, blocking the interaction between LAG-3 and MHC II, thereby relieving the inhibitory effect of LAG-3 on T cell activation and enhancing the anti-tumor immune response of T cells. Additionally, LAG-3 and PD-1 are both immune checkpoint receptors. Co-inhibition of LAG-3 and PD-1 can enhance immune responses and inhibit tumor growth. Therefore, IBI110 and its combination therapy with PD-1 monoclonal antibodies have great development potential in the treatment of locally advanced, recurrent, and late-stage solid tumors.
Based on the aforementioned foundation, this study intends to enroll patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC). The treatment protocol will involve neoadjuvant therapy and the TP regimen (paclitaxel and cisplatin), with/without IBI110 for neoadjuvant chemotherapy. Following neoadjuvant therapy, patients will undergo radical surgery, and adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological risk factors as appropriate. The primary endpoints of the study are efficacy and safety.
- Being tested
- Sintilimab, IBI110, Paclitaxel, Cis Platinum, Surgery
- Keywords
- Immune checkpoint inhibitor, Neoadjuvant chemotherapy, Induction chemotherapy, PD-1 inhibitor, LAG-3 inhibitor
- Medical subject headings
- Head and Neck Neoplasms, 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.
SintilimabDrug
PD-1 inhibitor
IBI110Drug
LAG-3 inhibitor
PaclitaxelDrug
Chemotherapy
Cis PlatinumDrug
Chemotherapy
SurgeryProcedure or surgery
Definitive surgery
Adjuvant radiationRadiation
Adjuvant radiotherapy or chemoradiotherapy based on post-operative pathologic findings.
| Study group | Role | What they receive |
|---|---|---|
| Cohort B: IBI110 and sintilimab and TP regimen | Experimental | The first phase is the dose-escalation stage, where fixed doses of IBI110 and sintilimab will be administered, and the doses of paclitaxel and cisplatin will be escalated to determine the Recommended Dose for expansion stage. This phase is divided into three dose groups: paclitaxel 135 mg/m² on day 2 and cisplatin 20 mg/m² on days 2-4; paclitaxel 150 mg/m² on day 2 and cisplatin 20 mg/m² on days 2-4; paclitaxel 175 mg/m² on day 2 and cisplatin 25 mg/m² on days 2-4. The accelerated dose-escalation method will be used.
The second phase is the fixed-dose expansion stage. They will receive the recommended doses of paclitaxel and cisplatin, combined with IBI110 200 mg on day 1 every 3 weeks administered intravenously, and sintilimab 200 mg on day 1 every 3 weeks administered intravenously.
All subjects will undergo radical surgery after neoadjuvant therapy. Adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological factors as appropriate. Receives: Drug: Sintilimab; Drug: IBI110; Drug: Paclitaxel; Drug: Cis Platinum; Procedure: Surgery; Radiation: Adjuvant radiation |
| Cohort A: sintilimab and TP regimen | Experimental | The enrolled patients will receive paclitaxel 175 mg/m² on day 2 and cisplatin 25 mg/m² on days 2-4, combined with sintilimab 200 mg on day 1 every 3 weeks administered intravenously, for a total of two cycles. All subjects will undergo radical surgery after neoadjuvant therapy. Adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological factors as appropriate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response
The major pathological response rate (MPR rate), defined as the presence of residual tumor components ≤10% in tumor bed of the primary tumor site and cervical lymph node.
Measured: Up to 3 months, post-surgery
Adverse Events related to treatment
Adverse Events related to treatment of sintilimab, IBI110, paclitaxel and cisplatin, per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 4 months
Secondary outcomes (5)
Pathologic complete response rate
Pathologic complete response rate
Measured: Up to 3 months, post-surgery
Objective response rate
Objective response rate of primary tumor and metastatic lymph nodes, per RECIST 1.1 criteria
Measured: Up to 2 months, prior to surgery
Progression-free survival rate
Progression-free survival rate
Measured: Up to 2 years
Overall survival rate
Overall survival rate
Measured: Up to 2 years
Quality of life asessment
Quality of life evaluation, based on EORTC QLQ-H\&N35 criteria
Measured: Up to 2 months, prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start26 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494943
- Sponsor's protocol ID
- Insight 3.0
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing will be based on the decision of pricinpal investigator, after consultation of potential use of the data.
Publications
Ou X, Zhai R, Wei W, Chen J, Ou D, Liao T, Xu T, Zhu Y, Wang Y, Huang S, Shi R, Wu B, Chen T, Li Y, Yang Z, Zhou C, Liu Y, Jiang Z, Zeng M, Liu X, Ji D, Ying H, Zhang Z, Hu C, Lu X, Ji Q, He X, Wang Y. Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial. Clin Cancer Res. 2024 Jan 17;30(2):344-355. doi: 10.1158/1078-0432.CCR-23-2398.
PubMed 37955629Long L, Zhang X, Chen F, Pan Q, Phiphatwatchara P, Zeng Y, Chen H. The promising immune checkpoint LAG-3: from tumor microenvironment to cancer immunotherapy. Genes Cancer. 2018 May;9(5-6):176-189. doi: 10.18632/genesandcancer.180.
PubMed 30603054Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.
PubMed 34986285
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial
- ClinicalTrials.gov ID
- NCT06494943
- Acronym / sponsor ID
- Insight 3.0
- Keywords
- Immune checkpoint inhibitor, Neoadjuvant chemotherapy, Induction chemotherapy, PD-1 inhibitor, LAG-3 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jul 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 study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).
Detailed description
The NCCN guidelines recommend that for resectable locally advanced HNSCC, the recommended treatment include surgery combined with postoperative adjuvant radiotherapy (chemoradiotherapy), or concurrent chemoradiotherapy; for locally extensive HNSCC, the guidelines recommend considering neoadjuvant chemotherapy, with subsequent selection of surgery or chemoradiotherapy based on the efficacy of the neoadjuvant chemotherapy. In recent years, multiple studies have shown that combining PD-1 inhibitors with neoadjuvant chemotherapy may help improve the pathological response rate of surgical resection.
LAG-3 (Lymphocyte Activation Gene 3) is a cell surface molecule co-expressed with CD4 and CD8 on activated CD4+ and CD8+ T cells, natural killer (NK) cells, B cells, and dendritic cells. LAG-3 is an activation-induced T cell receptor (TCR) co-receptor with high affinity for major histocompatibility complex (MHC) class II molecules, and it can directly inhibit TCR signal transduction in the immune response through its interaction with MHC II.
IBI110 can directly bind to LAG-3 on T cells, blocking the interaction between LAG-3 and MHC II, thereby relieving the inhibitory effect of LAG-3 on T cell activation and enhancing the anti-tumor immune response of T cells. Additionally, LAG-3 and PD-1 are both immune checkpoint receptors. Co-inhibition of LAG-3 and PD-1 can enhance immune responses and inhibit tumor growth. Therefore, IBI110 and its combination therapy with PD-1 monoclonal antibodies have great development potential in the treatment of locally advanced, recurrent, and late-stage solid tumors.
Based on the aforementioned foundation, this study intends to enroll patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC). The treatment protocol will involve neoadjuvant therapy and the TP regimen (paclitaxel and cisplatin), with/without IBI110 for neoadjuvant chemotherapy. Following neoadjuvant therapy, patients will undergo radical surgery, and adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological risk factors as appropriate. The primary endpoints of the study are efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort B: IBI110 and sintilimab and TP regimen | Experimental | Drug: Sintilimab, Drug: IBI110, Drug: Paclitaxel, Drug: Cis Platinum, Procedure: Surgery, Radiation: Adjuvant radiationThe first phase is the dose-escalation stage, where fixed doses of IBI110 and sintilimab will be administered, and the doses of paclitaxel and cisplatin will be escalated to determine the Recommended Dose for expansion stage. This phase is divided into three dose groups: paclitaxel 135 mg/m² on day 2 and cisplatin 20 mg/m² on days 2-4; paclitaxel 150 mg/m² on day 2 and cisplatin 20 mg/m² on days 2-4; paclitaxel 175 mg/m² on day 2 and cisplatin 25 mg/m² on days 2-4. The accelerated dose-escalation method will be used. The second phase is the fixed-dose expansion stage. They will receive the recommended doses of paclitaxel and cisplatin, combined with IBI110 200 mg on day 1 every 3 weeks administered intravenously, and sintilimab 200 mg on day 1 every 3 weeks administered intravenously. All subjects will undergo radical surgery after neoadjuvant therapy. Adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological factors as appropriate. |
| Cohort A: sintilimab and TP regimen | Experimental | –The enrolled patients will receive paclitaxel 175 mg/m² on day 2 and cisplatin 25 mg/m² on days 2-4, combined with sintilimab 200 mg on day 1 every 3 weeks administered intravenously, for a total of two cycles. All subjects will undergo radical surgery after neoadjuvant therapy. Adjuvant radiotherapy (chemoradiotherapy) will be administered postoperatively based on pathological factors as appropriate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent and willing to complete the study as per the protocol;
- Age ≥ 18 years and ≤ 75 years;
- Histologically confirmed head and neck squamous cell carcinoma, including primary sites in the oropharynx, oral cavity, larynx, and hypopharynx;
- Resectable locally advanced head and neck squamous cell carcinoma (AJCC 8th edition: Stage III-IVB);
- At least one measurable lesion before treatment, meeting the RECIST 1.1 criteria for "measurable disease";
Key exclusion criteria (22 listed)
- History of or concurrent other malignancies (excluding those that have been cured with a cancer-free survival period of more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma);
- Receipt of any of the following treatments:
- Uncontrolled cardiac clinical symptoms or diseases, such as:
- Severe infections (CTCAE > Grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or complications of infections. Baseline chest imaging indicating active pulmonary inflammation, symptoms and signs of infection within 4 weeks prior to the first use of the study drug, or requiring oral or intravenous antibiotics;
- Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except for autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, type 1 diabetes with a stable dose of insulin, vitiligo, or childhood asthma/allergies that have resolved without intervention in adulthood;
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 |
|---|---|---|
| SintilimabPD-1 inhibitor | Drug | Cohort B: IBI110 and sintilimab and TP regimen |
| IBI110LAG-3 inhibitor | Drug | Cohort B: IBI110 and sintilimab and TP regimen |
| PaclitaxelChemotherapy | Drug | Cohort B: IBI110 and sintilimab and TP regimen |
| Cis PlatinumChemotherapy | Drug | Cohort B: IBI110 and sintilimab and TP regimen |
| SurgeryDefinitive surgery | Procedure or surgery | Cohort B: IBI110 and sintilimab and TP regimen |
| Adjuvant radiationAdjuvant radiotherapy or chemoradiotherapy based on post-operative pathologic findings. | Radiation | Cohort B: IBI110 and sintilimab and TP regimen |
Primary outcome
Major pathological response
Time frame: Up to 3 months, post-surgery
The major pathological response rate (MPR rate), defined as the presence of residual tumor components ≤10% in tumor bed of the primary tumor site and cervical lymph node.
Adverse Events related to treatment
Time frame: Up to 4 months
Adverse Events related to treatment of sintilimab, IBI110, paclitaxel and cisplatin, per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
5 secondary outcomes
Pathologic complete response rate
Time frame: Up to 3 months, post-surgery
Objective response rate
Time frame: Up to 2 months, prior to surgery
Progression-free survival rate
Time frame: Up to 2 years
Overall survival rate
Time frame: Up to 2 years
Quality of life asessment
Time frame: Up to 2 months, prior to surgery
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 25 Feb 2025.
- Background: PubMed 37955629Ou X, Zhai R, Wei W, Chen J, Ou D, Liao T, Xu T, Zhu Y, Wang Y, Huang S, Shi R, Wu B, Chen T, Li Y, Yang Z, Zhou C, Liu Y, Jiang Z, Zeng M, Liu X, Ji D, Ying H, Zhang Z, Hu C, Lu X, Ji Q, He X, Wang Y. Induction Toripalimab and Chemotherapy for Organ Preservation in Locally Advanced Laryngeal and Hypopharyngeal Cancer: A Single-Arm Phase II Clinical Trial. Clin Cancer Res. 2024 Jan 17;30(2):344-355. doi: 10.1158/1078-0432.CCR-23-2398.
- Background: PubMed 30603054Long L, Zhang X, Chen F, Pan Q, Phiphatwatchara P, Zeng Y, Chen H. The promising immune checkpoint LAG-3: from tumor microenvironment to cancer immunotherapy. Genes Cancer. 2018 May;9(5-6):176-189. doi: 10.18632/genesandcancer.180.
- Background: PubMed 34986285Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.
- Individual participant dataSharing planned: No. IPD sharing will be based on the decision of pricinpal investigator, after consultation of potential use of the data.
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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 1/2 study testing Sintilimab, IBI110 and Paclitaxel in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, 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 18 inclusion and 22 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 25 Feb 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Major pathological response (time frame: Up to 3 months, post-surgery). The study lists 2 primary outcomes in all. 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 NCT06494943, which also lists 3 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 Feb 2025.