Oral Squamous Cell CarcinomaPhase 2CHANCENCT05611463
Camrelizumab Plus Docetaxel and Cisplatin in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients
A Phase 2 study testing Camrelizumab Plus Docetaxel and Cisplatin in people with Oral Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
the purpose of this study is to assess the efficacy and safety of camrelizumab plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab Plus Docetaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2020to 2 Jun 2023
- 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
- Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable oral squamous carcinoma with measurable lesions (spiral CT scan ≥ 10 mm, meeting RECIST 1.1 criteria).
- No prior treatment with any systemic antineoplastic agent, prior adjuvant or neoadjuvant therapy (other than PD-1/PDL-1 monoclonal antibody) is allowed, provided that it was completed at least 4 weeks prior to the first dose of study drug and all associated toxic events have returned to normal or to grade I or below as defined by CTCAE 4.03 classification.
- An ECOG score of 0 or 1.
- Expected survival of ≥ 12 weeks.
- Normal function of major organs within 2 weeks prior to treatment, i.e. meeting the following criteria.
- Bone marrow function: hemoglobin ≥ 100gg/L, white blood cell count ≥ 4.010^9/L or neutrophil count ≥ 2.010^9/L and platelet count ≥ 10010^9/L without transfusion or with colony-stimulating factor support therapy.
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- Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal.
- Renal: blood creatinine level less than 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L. Urine protein <+, if urine protein + then total 24 hour protein must be <500mg.
- Blood glucose: within normal range and/or with diabetic patients on treatment but with stable blood glucose control.
- Pulmonary function: baseline FEV1 of at least 2L, if baseline FEV1 < 2L, FEV1 >800ml is expected after surgery as assessed by a surgical specialist.
- Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency.
- Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose of the test drug; men of childbearing potential or women of childbearing potential must use a highly effective contraceptive method (e.g., oral contraceptive pill, intrauterine device, abstinence from sexual intercourse, or barrier contraceptive method combined with spermicide) throughout the trial and continue to use contraception for 12 months after the end of treatment.
Who cannot join
- Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy. Patients who are currently receiving antineoplastic therapy.
- Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study drug.
- Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; patients who require medical intervention with bronchodilators (asthma, on the other hand, cannot be included).
- Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppressive purposes (doses >10 mg/day prednisone or other equipotent hormone) and are continuing to use them within 2 weeks prior to enrollment.
- Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first administration of the study drug.
- Positive test results for HIV antibodies or syphilis spirochete antibodies. Patients with active hepatitis B or C:
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- If HBsAg or HBcAb is positive, add HBV DNA test (the result is higher than the upper limit of the normal range).
- Additional HCV RNA testing if positive for HCV antibodies (results above the upper limit of the normal range).
- Persons with known hypersensitivity to recombinant humanized PD-1 monoclonal antibody drugs and their components.
- Massive pleural or ascites fluid with clinical symptoms and requiring symptomatic management.
- Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease, asthma) or a history of active tuberculosis.
- Have any clinical problems beyond their control, including but not limited to: Persistent or active (severe) infection;
- Poorly controlled diabetes;
- Cardiac disease (Class III/IV congestive heart failure or heart block as defined by the New York Heart Association);
- Have or suspect autoimmune disease, or a history of autoimmune disease or syndrome requiring steroid/immunosuppressive systemic therapy, such as: hypopituitaritis, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
- Deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism within 6 months prior to first dose.
- Abnormal coagulation (INR > 2.0, PT > 16s), with bleeding tendency or on thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low-molecular heparin.
- Those who had clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to randomization, such as daily cough/hemoptysis of 2.5 ml or more, gastrointestinal bleeding, esophagogastric fundic varices at risk of bleeding, bleeding gastric ulcers or suffering from vasculitis, etc., may be reviewed if the fecal occult blood is positive at baseline, and if it is still positive after review, gastroscopy is required, and if gastroscopy indicates severe esophagogastric fundic varices cannot be enrolled (except for those who underwent gastroscopy 3 months or less before enrollment to exclude such conditions).
- Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, etc.)
- Have received a stem cell transplant or organ transplant.
- Those with a history of psychotropic substance abuse and unable to abstain or a history of mental disorders.
- Other serious, acute or chronic medical conditions or laboratory test abnormalities that, in the judgment of the investigator, may increase the risk associated with participation in the study, or may interfere with the interpretation of study results.
- The patient had a history of other malignancies within five years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Guoxin Ren, PHD, 021-23271699, renguoxincn@sina.com
About this study
Official title: Camrelizumab Plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients(CHANCE): an Open-label, Single-arm, Phase II Trial
the purpose of this study is to assess the efficacy and safety of camrelizumab plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients
Read the detailed description
Head and neck cancer is the sixth most common cancer in the world, with more than 550,000 cases and 300,000 deaths worldwide each year. About 75,000 Chinese suffer from head and neck cancer each year, and currently, there are a total of 176,000 patients with head and neck cancer in China. More than 95% of head and neck cancers are squamous cell carcinomas, and head and neck squamous cell carcinoma (SCCHN) disrupts and affects the patient's appearance and basic physiological functions, sensory functions, and language functions, thus affecting the patient's quality of life. Most head and neck squamous cell carcinomas are incurable, and they will develop local recurrence and metastasis.
More than 60% of patients with head and neck squamous cell carcinoma have stage III or IV disease characterized by large size tumors with marked local invasion, evidence of metastasis to regional lymph nodes, or both. Locally advanced head and neck cancer has a high risk of local recurrence and distant metastasis and a poor prognosis. Over the past 20 years, multimodal treatment approaches have steadily improved cure rates while striving to maintain patient function and quality of life.
This clinical study involved Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (Camrelizumab), a Class 1 new therapeutic biological product developed by Jiangsu Hengrui Medicine Co., Ltd., which was approved by NMPA in May 2019 for the treatment of relapsed or refractory classical Hodgkin's lymphoma, by NMPA in March 2020 for the treatment of patients with advanced hepatocellular carcinoma who have received sorafenib and/or oxaliplatin-based systemic chemotherapy, and in June 2020 for the second-line treatment of esophageal squamous cell carcinoma and first-line treatment of non-squamous non-small cell lung cancer.
Preclinical study data showed that camrelizumab had comparable in vivo efficacy and safety compared with similar drugs abroad. Since 2015, Hengrui has simultaneously carried out a number of phase I/II clinical trials in Australia and China to preliminarily verify the safety, tolerability and efficacy of camreibizumab in the treatment of advanced solid tumors.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Camrelizumab Plus Docetaxel and Cisplatin
- 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.
Camrelizumab Plus Docetaxel and CisplatinDrug
Also called SHR-1210+DTX+Platinol
Camrelizumab (200 mg) was administered once on day 1 every 3 weeks until disease progression, intolerable toxicity, physician or participant decision or 35 cycles, whichever occurred first. Chemotherapy was received docetaxel (75 mg/m2) and cisplatin (75 mg/m²) on day 2 every 3 weeks for six cycles.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Plus Docetaxel and Cisplatin | Experimental | Participants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus cisplatin 75 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle (6 cycle maximum). Receives: Drug: Camrelizumab Plus Docetaxel and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for treatment arm
Measured: 24 months
Secondary outcomes (4)
Objective remission rate (ORR)
radiographically confirmed complete or partial response
Measured: 24 months
overall survival
the time from enrolled to death from any cause
Measured: 24 months
progression -free survival
the time from enrolled to radiographically confirmed disease progression or death from any cause (whichever occurred first)
Measured: the time from enrolled to radiographically confirmed disease progression or death from any cause (whichever occurred first)
Duration of remission (DOR)
the time from first documented complete or partial response to radiographically confirmed disease progression or death from any cause, whichever occurred first
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 posted10 Nov 2022
- Study start2 Jun 2020
- Primary completion2 Dec 2022 (estimated)
- Study completion2 Jun 2023 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yue He, M.D., Principal investigator, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611463
- Sponsor's protocol ID
- SH9H-2019-T354-2
- Acronym
- CHANCE
- Status last verified
- Sep 2022
- First submitted
- 14 Jun 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients(CHANCE): an Open-label, Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT05611463
- Acronym / sponsor ID
- CHANCE / SH9H-2019-T354-2
- Conditions
- Oral Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 2 Dec 2022 (estimated)
- Study completion
- 2 Jun 2023 (estimated)
- First posted
- 10 Nov 2022 (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 assess the efficacy and safety of camrelizumab plus Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients
Detailed description
Head and neck cancer is the sixth most common cancer in the world, with more than 550,000 cases and 300,000 deaths worldwide each year. About 75,000 Chinese suffer from head and neck cancer each year, and currently, there are a total of 176,000 patients with head and neck cancer in China. More than 95% of head and neck cancers are squamous cell carcinomas, and head and neck squamous cell carcinoma (SCCHN) disrupts and affects the patient's appearance and basic physiological functions, sensory functions, and language functions, thus affecting the patient's quality of life. Most head and neck squamous cell carcinomas are incurable, and they will develop local recurrence and metastasis.
More than 60% of patients with head and neck squamous cell carcinoma have stage III or IV disease characterized by large size tumors with marked local invasion, evidence of metastasis to regional lymph nodes, or both. Locally advanced head and neck cancer has a high risk of local recurrence and distant metastasis and a poor prognosis. Over the past 20 years, multimodal treatment approaches have steadily improved cure rates while striving to maintain patient function and quality of life.
This clinical study involved Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection (Camrelizumab), a Class 1 new therapeutic biological product developed by Jiangsu Hengrui Medicine Co., Ltd., which was approved by NMPA in May 2019 for the treatment of relapsed or refractory classical Hodgkin's lymphoma, by NMPA in March 2020 for the treatment of patients with advanced hepatocellular carcinoma who have received sorafenib and/or oxaliplatin-based systemic chemotherapy, and in June 2020 for the second-line treatment of esophageal squamous cell carcinoma and first-line treatment of non-squamous non-small cell lung cancer.
Preclinical study data showed that camrelizumab had comparable in vivo efficacy and safety compared with similar drugs abroad. Since 2015, Hengrui has simultaneously carried out a number of phase I/II clinical trials in Australia and China to preliminarily verify the safety, tolerability and efficacy of camreibizumab in the treatment of advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Plus Docetaxel and Cisplatin | Experimental | Drug: Camrelizumab Plus Docetaxel and CisplatinParticipants receive Camrelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months;plus cisplatin 75 mg/m^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum); plus docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle (6 cycle maximum). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with histologically confirmed post-surgical recurrent/metastatic or locally advanced inoperable oral squamous carcinoma with measurable lesions (spiral CT scan ≥ 10 mm, meeting RECIST 1.1 criteria).
- No prior treatment with any systemic antineoplastic agent, prior adjuvant or neoadjuvant therapy (other than PD-1/PDL-1 monoclonal antibody) is allowed, provided that it was completed at least 4 weeks prior to the first dose of study drug and all associated toxic events have returned to normal or to grade I or below as defined by CTCAE 4.03 classification.
- An ECOG score of 0 or 1.
- Expected survival of ≥ 12 weeks.
- Normal function of major organs within 2 weeks prior to treatment, i.e. meeting the following criteria.
Key exclusion criteria (23 listed)
- Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy. Patients who are currently receiving antineoplastic therapy.
- Patients who have participated or are participating in a clinical trial of another drug/therapy within 4 weeks prior to the first dose of the study drug.
- Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; patients who require medical intervention with bronchodilators (asthma, on the other hand, cannot be included).
- Patients who are on immunosuppressive, or systemic hormone therapy for immunosuppressive purposes (doses >10 mg/day prednisone or other equipotent hormone) and are continuing to use them within 2 weeks prior to enrollment.
- Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the first administration of the study drug.
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 |
|---|---|---|
| Camrelizumab Plus Docetaxel and CisplatinAlso: SHR-1210+DTX+PlatinolCamrelizumab (200 mg) was administered once on day 1 every 3 weeks until disease progression, intolerable toxicity, physician or participant decision or 35 cycles, whichever occurred first. Chemotherapy was received docetaxel (75 mg/m2) and cisplatin (75 mg/m²) on day 2 every 3 weeks for six cycles. | Drug | Camrelizumab Plus Docetaxel and Cisplatin |
Primary outcome
Participants Experiencing an Adverse Event (AE)
Time frame: 24 months
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for treatment arm
4 secondary outcomes
Objective remission rate (ORR)
Time frame: 24 months
overall survival
Time frame: 24 months
progression -free survival
Time frame: the time from enrolled to radiographically confirmed disease progression or death from any cause (whichever occurred first)
Duration of remission (DOR)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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. This study is not recruiting at the moment.
Yue He, M.D. principal investigator
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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 Camrelizumab Plus Docetaxel and Cisplatin in people with Oral Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 12 inclusion and 23 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 10 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Ren, PHD (021-23271699, renguoxincn@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Experiencing an Adverse Event (AE) (time frame: 24 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 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.