Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaPhase 2Carpp-1NCT04882462
Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of R/M HNSCC.
A Phase 2 study testing Nimotuzumab, Sintilimab and Chemotherapy drug in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by The First Affiliated Hospital of Soochow University.
Trial summary
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab, Sintilimab and Chemotherapy drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Voluntary and sign a consent form;
- Age 18-75 years old, gender unlimited;
- Histology or imaging diagnosed as R/M HNSCC, patients haven't received any anti-tumor treatment for R/M HNSCC; Including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, paranasal sinus and nasal cavity cancer, etc.;
- PD-L1 immunohistochemistry and EGFR immunohistochemistry should be performed on tumor tissue samples;
- according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one measurable lesion;
- Not received any previous systemic antitumor therapy for R/M HNSCC. Subjects who had previously received adjuvant/neoadjuvant chemotherapy, or had received radical chemoradiotherapy for advanced disease, were allowed to be enrolled in this study if the interval between disease progression or recurrence and the end of the last treatment (including chemotherapy /EGFR monoclonal antibody /EGFR-TKI/ antiangiogenic agents) was beyond 6 months. Radiotherapy for individual recurrent and/or metastatic lesions cannot be ruled out.
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- ECOG PS 0-2
- Expected survival time ≥ 3 months;
- Enough organ function, the participants need to satisfy the following laboratory indicators: 1) nearly 14 days without the use of granulocyte colony stimulating factor, absolute neutrophil count ≥ 1.5 × 109/L; 2) Platelets ≥100×109/L in the case of no blood transfusion in the last 14 days; 3) Hemoglobin ≥9g/dL (90g/L) or≥5.6 mmol/L in the absence of blood transfusion or erythropoietin treatment within the last 14 days; 4) total bilirubin ≤1.5×upper limit of normal (ULN); 5) Aspartate aminotransferase (AST) /alanine aminotransferase (ALT) ≤2.5×ULN, or AST/ALT≤5×ULN in subjects with liver metastasis; 6) Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 mL /min; 7) Good coagulant function; 8) Thyroid function is normal; 9) Myocardial enzyme spectrum is normal;
- For females of reproductive age, a pregnancy test with negative results should be performed within 3 days prior to receiving the first dosing (cycle 1 day 1);
- To avoid pregnancy, an effective contraception should used for female patients.
Who cannot join
- squamous cell carcinoma of skin;
- Patients with uncured malignancies other than R/M HNSCC diagnosed within 5 years prior to initial administration;
- Participating in other clinical studies, or receiving other investigational drugs or using investigational devices within 4 weeks prior to first dosing;
- Have received any other anti-tumor treatment for R/M HNSCC, including PD-1 inhibitor, PD-L1 inhibitor, CD137 inhibitor, EGFR monoclonal antibody, EGFR-TKI, anti-angiogenic drugs, etc.;
- Major surgery or chemotherapy was performed within 4 weeks prior to enrollment;
- Have received immunomodulatory drugs (including thymosin, interferon, interleukin);
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- Active autoimmune disease with systemic therapy (such as glucocorticoids or immunosuppressants) within 2 years prior to initial administration. Alternative therapy (e.g. thyroxine, insulin, etc.) is not considered systemic therapy.
- Have received systemic glucocorticoid therapy within 7 days prior to enrollment; Note: Physiological dose of glucocorticoids (≤10 mg/ day of prednisone or equivalent drugs) is allowed.
- Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Allergic to the study drugs;
- Have not fully recovered from toxicity and/or complications caused by any intervention prior to enrollment;
- History of human immunodeficiency virus (HIV) infection;
- Untreated active hepatitis B; Note: Hepatitis B patients who meet the following criteria can also be enrolled: 1) HBV DNA<1000 copies /ml (200 IU/ml) prior to enrollment; 2) anti-HBcAg(+), HBsAg (-), anti-HBsAg (-), and HBV DNA(-), prophylactic anti-HBV therapy is not required, but virus reactivation needs to be closely monitored;
- Active HCV infection;
- Live vaccine was given within 30 days;
- Pregnant or lactating women;
- Any serious or uncontrollable systemic disease;
- Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Single-arm Study of Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The main endpoint is progression free survival (PFS); the secondary endpoint are objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
- Being tested
- Nimotuzumab, Sintilimab, Chemotherapy drug
- 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.
NimotuzumabDrug
Nimotuzumab, 400mg, intravenously every 3 weeks, for at least 18 weeks
SintilimabDrug
Sintilimab, 200mg, intravenously every 3 weeks, for at least 18 weeks;
Chemotherapy drugDrug
Chemotherapy drugs were selected by the investigator, every 3 weeks, for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Drug: Nimotuzumab; Drug: Sintilimab; Drug: Chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: Up to 12 months
Secondary outcomes (3)
ORR
objective response rate
Measured: Up to 12 months
DCR
disease control rate
Measured: Up to 12 months
OS
overall survival
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd., Cinda Biopharmaceutical (Suzhou) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882462
- Sponsor's protocol ID
- BPL-IST-H&N-20210318
- Acronym
- Carpp-1
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm Study of Sintilimab and Nimotuzumab Combined With Chemotherapy for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04882462
- Acronym / sponsor ID
- Carpp-1 / BPL-IST-H&N-20210318
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd., Cinda Biopharmaceutical (Suzhou) Co., Ltd.
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 2021 (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 clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of Sintilimab and Nimotuzumab in combination with chemotherapy in patients with newly diagnosed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The main endpoint is progression free survival (PFS); the secondary endpoint are objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Nimotuzumab, Drug: Sintilimab, Drug: Chemotherapy drug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntary and sign a consent form;
- Age 18-75 years old, gender unlimited;
- Histology or imaging diagnosed as R/M HNSCC, patients haven't received any anti-tumor treatment for R/M HNSCC; Including oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, paranasal sinus and nasal cavity cancer, etc.;
- PD-L1 immunohistochemistry and EGFR immunohistochemistry should be performed on tumor tissue samples;
- according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one measurable lesion;
Key exclusion criteria (18 listed)
- squamous cell carcinoma of skin;
- Patients with uncured malignancies other than R/M HNSCC diagnosed within 5 years prior to initial administration;
- Participating in other clinical studies, or receiving other investigational drugs or using investigational devices within 4 weeks prior to first dosing;
- Have received any other anti-tumor treatment for R/M HNSCC, including PD-1 inhibitor, PD-L1 inhibitor, CD137 inhibitor, EGFR monoclonal antibody, EGFR-TKI, anti-angiogenic drugs, etc.;
- Major surgery or chemotherapy was performed within 4 weeks prior to enrollment;
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 |
|---|---|---|
| NimotuzumabNimotuzumab, 400mg, intravenously every 3 weeks, for at least 18 weeks | Drug | single arm |
| SintilimabSintilimab, 200mg, intravenously every 3 weeks, for at least 18 weeks; | Drug | single arm |
| Chemotherapy drugChemotherapy drugs were selected by the investigator, every 3 weeks, for 18 weeks | Drug | single arm |
Primary outcome
Progression Free Survival
Time frame: Up to 12 months
3 secondary outcomes
ORR
Time frame: Up to 12 months
DCR
Time frame: Up to 12 months
OS
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab, Sintilimab and Chemotherapy drug in people with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, run by The First Affiliated Hospital of Soochow University.
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 18 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: status not confirmed, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juying Zhou (13962142066, ci49802974@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: Up to 12 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 12 May 2021.