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New treatment option for Oral Squamous Cell Carcinoma
Official title Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients
ClinicalTrials.gov ID: NCT05069857
What this study is testing
What is Camrelizumab (anti-PD-1 inhibitor)?
Camrelizumab (anti-PD-1 inhibitor) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oral squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy of neoadjuvant anti-PD-1 plus anti-VEGFR therapy for patients with locally advanced and resectable oral squamous cell carcinoma, and the CPS\>10 in the biopsy samples.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18 to 75
- Gender: Male and female
- ECOG Score: 0-2
- Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
- Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
You likely can't join if
- Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
- Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the...
- Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
- Uncontrollable hypertension (systolic blood pressure \> after antihypertensive medication; 150mmHg and/or diastolic blood pressure \> 90mmHg) or...
- Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
- Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
See the full eligibility criteria
- Age: 18 to 75
- Gender: Male and female
- ECOG Score: 0-2
- Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
- Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
- The combined positive score (CPS score) of PD-L1 expression \> 10
- Has signed informed consent
- Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
- Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)
- Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
- Uncontrollable hypertension (systolic blood pressure \> after antihypertensive medication; 150mmHg and/or diastolic blood pressure \> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as...
- Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
- Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
- Renal function: serum creatinine \> 1.5 times the normal upper limit
- Has a history of maxillofacial and neck radiotherapy
- Pregnant or lactating women
- Participation in other clinical studies within 30 days prior to enrollment
- Other conditions that the investigator considers inappropriate for participation
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.