Oral Squamous Cell Carcinoma (OSCC)Phase 2OSCCNCT06728618
Preoperative Tislelizumab -Cetuximab - Chemotherapy Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC), Resectable Oral and Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Dec 2024to Mar 2028
- 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
- Participants must have histologically or cytologically confirmed locoregionally recurrent oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils).
- Participants must have documented time of ≥ 16 weeks from completion of prior curative intent treatment for OSCC (surgery and/or radiation therapy with/without platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence.
- Age ranges from 18 to 75 years old
- ECOG performance status 0 or 1.
- Expected survival ≥ 12 weeks.
- The participants are clinically evaluated to be eligible for salvage surgery and must be intended to undergo salvage surgery.
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- There must be at least one clinically assessable lesion according to the RECIST V1.1 criteria prior to treatment.
- The participants may have any human papillomavirus (HPV) status of the tumor. Patients with oropharyngeal cancer need to undergo HPV testing, including p16 immunohistochemistry and/or confirmatory HPV polymerase chain reaction (PCR) or in situ hybridization (ISH) testing.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and continue contraception for 12 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participants must have adequate organ and marrow function as defined below: The function of important organs meets the following requirements: (1) normal bone marrow reserve function, white blood cell (WBC) ≥ 3.0 × 10 ^ 9/L; Neutrophil count (NEUT) ≥ 1.5 × 10 ^ 9/L, platelet count (PLT) ≥ 100 × 10 ^ 9/L, hemoglobin (Hb) ≥ 90 g/L; (2) Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥ 50 ml/min (Cockcroft Gault formula); (3) Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); AST or ALT levels ≤ 3 times the upper limit of normal (ULN); (4) Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
- The participants voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Has known distant metastasis of the disease.
- Has received chemotherapy or radiotherapy for curative treatment of oral/oropharyngeal squamous cell carcinoma within the 16 weeks prior to enrollment in the study.
- Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
- Has received live or attenuated vaccines within 30 days prior to the first dose of Tislelizumab, inactivated vaccines are allowed.
- Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.
- Has an active infection that requires systematic treatment; Has a history of non -infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease; Has a known history of hepatitis B (defined as positive for hepatitis B surface antigen [HBsAg]) or known history of active hepatitis C virus (defined as detection of HCV RNA [qualitative]) infection; Has a known history of human immunodeficiency virus (HIV) infection.
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- Has received allogeneic tissue/solid organ transplantation.
- Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 2) with the exception of alopecia.
- Has obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, and heart disease grade 2 or above diagnosed according to the New York Heart Association (NYHA) classification criteria within 3 months prior to the enrollment)。
- Has severe clinical infection (>NCI-CTCAE 5.0 Level 2 infection);
- Has uncontrollable hypertension (systolic blood pressure>150mmHg and/or diastolic blood pressure>90mmHg after treatment with antihypertensive drugs) or clinically significant cardiovascular diseases - such as cerebrovascular accidents (≤ 6 months before enrollment), myocardial infarction (≤ 6 months before enrollment), unstable angina, congestive heart failure classified as Grade II or above by the New York Heart Association (NYHA), or severe arrhythmias that cannot be controlled with medication or have potential impact on experimental treatment.
- Pregnant women are not allowed to participate. Breast-feeding women who participate in this study should stop breast-feeding.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has participated in other clinical studies within 30 days prior to enrollment.
- Other situations that researchers consider unsuitable for participation in the study.
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
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Tong Ji, PhD, 86-13651658767, ji.tong@zs-hospital.sh.cn
About this study
Official title: A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Tislelizumab -Cetuximab - TP(cisplatin and Albumin-paclitaxel) Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.
Read the detailed description
Despite multimodality curative approaches to treat patients with oral/oropharyngeal squamous cell carcinoma (OSCC), approximately 30-40% of patients recur locally. Recurrent OSCC contributes to significant morbidity and portends overall poor survival, reflecting a situation that is difficult to treat owing to the effects of prior therapy (surgery, radiation, and/or chemotherapy) on the delicate structures of the head and neck. Both the NCCN and the CSCO head and neck cancer treatment guidelines recommend salvage surgery as a Grade I recommended curative treatment method whenever possible, as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. However, salvage surgery is extremely challenging due to delicate structures of the head and neck.
Previous studies have recommended that the combination of targeted therapy (cetuximab) and chemotherapy (cisplatin, paclitaxel) has effective anti-tumor effects for recurrent/metastatic head and neck squamous cell carcinoma. Recently, newer approaches also have shown favorable safety and evidence of pathologic response when using immune-checkpoint inhibitors as neoadjuvant therapy prior to upfront, curative-intent surgery in resectable head and neck cancer. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Locally recurrent patients undergoing salvage therapy are understudied and deserves further exploration.
This is a prospective, open label, single arm, phase II, single center interventional study of neoadjuvant combination therapy of immunotherapy (Tislelizumab), targeted therapy (cetuximab), with chemotherapy (cisplatin and nab-paclitaxel) followed by salvage surgery and followed by adjuvant immunotherapy (Tislelizumab), targeted therapy (cetuximab) in patients with resectable recurrent oral/oropharyngeal squamous cell carcinoma.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC), Resectable Oral and Oropharyngeal Squamous Cell Carcinoma, Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
- Being tested
- Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel
- 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.
Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxelDrug
Neoadjuvant treatment: the participants will receive Tislelizumab 200 mg, Cisplatin 75 mg/m2, Nab-paclitaxel 260 mg/m2 (each 3-week cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles.
Adjuvant treatment: the participants will receive Tislelizumab 200 mg (each 3-week cycle, a total of 8 cycle) and Cetuximab (250 mg/m2, each 2-week, a total of 12 cycle) for a total of half a year.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Neoadjuvant Treatment + Salvage Surgery + Adjuvant Treatment | Experimental | Neoadjuvant treatment: The participants will receive 2 cycles of combination therapy (Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel).
Salvage surgery: Primary tumor resection and/or lymph node dissection surgery 3-6 weeks from cycle 2 day 1.
Adjuvant treatment: 3-8 weeks post-surgery and upto a total of half a year. The participants will receive Tislelizumab (q3w) and Cetuximab (q2w) therapy.
Interventions:
Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel Receives: Drug: Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Pathological Response (mPR)
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
Measured: 2 months
Secondary outcomes (6)
Rate of Pathologic complete response (PCR)
Pathologic complete response (PCR) is defined as having no invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced PCR.
Measured: 2 months
1 year Event-free Survival (EFS) Rate
EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1
Measured: 12 months
2 year Event-free Survival (EFS) Rate
EFS is the time from the date of study entry to the date of first record of disease progression as defined by RECIST 1.1
Measured: 24 months
1 year Overall Survival (OS) Rate
OS is the time from study entry to death due to any cause
Measured: 12 months
2 year Overall Survival (OS) Rate
OS is the time from study entry to death due to any cause
Measured: 24 months
Adverse Events (AEs)
Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728618
- Sponsor's protocol ID
- B2024-369R2
- Acronym
- OSCC
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Tislelizumab -Cetuximab - TP(cisplatin and Albumin-paclitaxel) Followed by Salvage Surgery and Adjuvant Tislelizumab -Cetuximab for Resectable, Locally Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06728618
- Acronym / sponsor ID
- OSCC / B2024-369R2
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (SCC), Resectable Oral and Oropharyngeal Squamous Cell Carcinoma, Recurrent Oral and Oropharyngeal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Dec 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.
The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Tislelizumab), targeted therapy (Cetuximab), with chemotherapy (Cisplatin and Nab-paclitaxel) as a possible treatment before and after salvage surgery for locally recurrent oral/pharyngeal squamous cell carcinoma. The combination of Tislelizumab，Cetuximab, Cisplatin and Nab-paclitaxel will be given prior to your surgery, while Tislelizumab and Cetuximab will be continued for approximately half a year after surgery.
Detailed description
Despite multimodality curative approaches to treat patients with oral/oropharyngeal squamous cell carcinoma (OSCC), approximately 30-40% of patients recur locally. Recurrent OSCC contributes to significant morbidity and portends overall poor survival, reflecting a situation that is difficult to treat owing to the effects of prior therapy (surgery, radiation, and/or chemotherapy) on the delicate structures of the head and neck. Both the NCCN and the CSCO head and neck cancer treatment guidelines recommend salvage surgery as a Grade I recommended curative treatment method whenever possible, as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. However, salvage surgery is extremely challenging due to delicate structures of the head and neck.
Previous studies have recommended that the combination of targeted therapy (cetuximab) and chemotherapy (cisplatin, paclitaxel) has effective anti-tumor effects for recurrent/metastatic head and neck squamous cell carcinoma. Recently, newer approaches also have shown favorable safety and evidence of pathologic response when using immune-checkpoint inhibitors as neoadjuvant therapy prior to upfront, curative-intent surgery in resectable head and neck cancer. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Locally recurrent patients undergoing salvage therapy are understudied and deserves further exploration.
This is a prospective, open label, single arm, phase II, single center interventional study of neoadjuvant combination therapy of immunotherapy (Tislelizumab), targeted therapy (cetuximab), with chemotherapy (cisplatin and nab-paclitaxel) followed by salvage surgery and followed by adjuvant immunotherapy (Tislelizumab), targeted therapy (cetuximab) in patients with resectable recurrent oral/oropharyngeal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Neoadjuvant Treatment + Salvage Surgery + Adjuvant Treatment | Experimental | Drug: Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxelNeoadjuvant treatment: The participants will receive 2 cycles of combination therapy (Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel). Salvage surgery: Primary tumor resection and/or lymph node dissection surgery 3-6 weeks from cycle 2 day 1. Adjuvant treatment: 3-8 weeks post-surgery and upto a total of half a year. The participants will receive Tislelizumab (q3w) and Cetuximab (q2w) therapy. Interventions: Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have histologically or cytologically confirmed locoregionally recurrent oral/oropharyngeal squamous cell carcinoma (including tongue, lips, gums, cheeks, floor of mouth, hard palate, soft palate, posterior molar area, lateral pharyngeal wall, posterior pharyngeal wall, tonsils).
- Participants must have documented time of ≥ 16 weeks from completion of prior curative intent treatment for OSCC (surgery and/or radiation therapy with/without platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence.
- Age ranges from 18 to 75 years old
- ECOG performance status 0 or 1.
- Expected survival ≥ 12 weeks.
Key exclusion criteria (15 listed)
- Has known distant metastasis of the disease.
- Has received chemotherapy or radiotherapy for curative treatment of oral/oropharyngeal squamous cell carcinoma within the 16 weeks prior to enrollment in the study.
- Has received therapy treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T cell co stimulatory or checkpoint pathways).
- Has received live or attenuated vaccines within 30 days prior to the first dose of Tislelizumab, inactivated vaccines are allowed.
- Has received immunosuppressive drugs within 14 days prior to the first dose of study drug, nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e. not exceeding 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) are allowed.
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 |
|---|---|---|
| Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxelNeoadjuvant treatment: the participants will receive Tislelizumab 200 mg, Cisplatin 75 mg/m2, Nab-paclitaxel 260 mg/m2 (each 3-week cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Tislelizumab 200 mg (each 3-week cycle, a total of 8 cycle) and Cetuximab (250 mg/m2, each 2-week, a total of 12 cycle) for a total of half a year. | Drug | Experimental: Neoadjuvant Treatment + Salvage Surgery + Adjuvant Treatment |
Primary outcome
Rate of Major Pathological Response (mPR)
Time frame: 2 months
Major pathologic response (mPR) is defined as having ≤ 10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes as assessed by pathologists. Rate is the proportion of treated participants who experienced mPR
6 secondary outcomes
Rate of Pathologic complete response (PCR)
Time frame: 2 months
1 year Event-free Survival (EFS) Rate
Time frame: 12 months
2 year Event-free Survival (EFS) Rate
Time frame: 24 months
1 year Overall Survival (OS) Rate
Time frame: 12 months
2 year Overall Survival (OS) Rate
Time frame: 24 months
Adverse Events (AEs)
Time frame: 24 months
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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 Drug: Tislelizumab, Cetuximab, Cisplatin and Nab-paclitaxel in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (SCC), run by Shanghai Zhongshan Hospital 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 11 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 11 Dec 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 Tong Ji, PhD (86-13651658767, ji.tong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Pathological Response (mPR) (time frame: 2 months). 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 11 Dec 2024.