Esophageal Squamous Cell CarcinomaPhase 2NCT04767295
A Study of Camrelizumab Combined With Chemotherapy as Neoadjuvant Therapy in Adcanced Esophageal Squamous Cell Carcinoma (ESCC)
A Phase 2 study testing Camrelizumab, Albumin Paclitaxel, Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and platinum chemotherapy in the preoperative treatment of locally advanced thoracic esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Camrelizumab, Albumin Paclitaxel, Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form before any trial-related procedures are implemented;
- Age 18-70 years, both men and women;
- pathologically confirmed thoracic esophageal squamous cell carcinoma;
- The clinical staging is T3-4a (potentially resectable) N0-2 (PET/CT or cervical, chest and abdomen CT + intra-esophageal ultrasound staging, except those with N3 stage); T1-2N1-2 can be included in the study, T4b, T1-2N0, carcinoma in situ are all excluded;
- The longitudinal length of the tumor is less than 8cm;
- Patients can be followed up for a long time and cooperate with treatment;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; life expectancy> 6 months;
- No other treatments including chemotherapy, radiotherapy, Chinese medicine treatment, etc. were used before selection.
- There is no history of radiotherapy in the chest cavity.
- Hematopoietic function is good before treatment, which is defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L (No blood transfusion within 7 days or no erythropoietin (EPO) dependence);
- Liver function is good before treatment, defined as total bilirubin level ≤ upper normal limit (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 1.5 times ULN;
- Good renal function before treatment, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); urine protein in routine examination of urine is less than 2+, or 24-hour urine Protein quantitative <1g;
- Good coagulation function before treatment, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, they can also be included in this trail as long as the PT is within the intended range of anticoagulation drugs;
- For female subjects of childbearing age, they should have a negative urine or serum pregnancy test within 3 days before receiving the first study drug administration (cycle 1, day 1). If the urine pregnancy test result cannot be confirmed as negative, blood pregnancy test is required. If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, a method with a failure rate of less than 1% per year) and continue until at least 180 days after stopping the trial treatment.
Who cannot join
- Medical history of malignant tumors in other parts, excluding curable non-melanoma skin cancer, radically excised cervical carcinoma in situ, and malignant tumors that have been cured for more than 5 years;
- Pregnant or breast-feeding patients who have fertility but have not taken contraceptive measures;
- Those who are allergic to the study drug camrelizumab, paclitaxel or platinum;
- Previous peripheral neuropathy (whether primary or secondary);
- Severe comorbidities: large-area myocardial infarction, myocardial infarction within 6 months, history of cerebral infarction, heart function ≥ grade III, history of mental illness and severe diabetes, severe pulmonary dysfunction, or other conditions that are not suitable for surgery;
- Participate in other clinical trials at present or within four weeks before being selected;
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- Simultaneous treatment with other anti-cancer drugs (including anti-cancer Chinese medicine);
- Have a history of organ transplantation;
- Those who cannot cooperate because of dementia or mental disorders;
- Cachexia, weight loss over the past six months> 10%;
- Histology contains non-squamous carcinoma components, such as small cell carcinoma, adenocarcinoma, etc.;
- Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug;
- Have received systemic treatment with anti-cancer indications Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration; those with previous partial gastrectomy, bowel surgery history, or those who are not suitable for minimally invasive surgery are excluded from the group;
- There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; received solid organ or blood system transplantation;
- Active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
- Diagnosis of immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the first administration of the study; physiological dose of glucocorticoids (≤10 mg/ day of prednisone or its equivalent) is allowed;
- Before starting treatment, have not fully recovered from the toxicity and/or complications caused by any intervention (ie ≤ Grade 1 or reach baseline, excluding fatigue or hair loss);
- A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year before the first administration or current existing in interstitial lung disease;
- Active infections such as tuberculosis that require systemic treatment;
- Known mental illness or drug abuse that may affect compliance with the test requirements;
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive);
- Untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for selection: HBV viral load must be <1000 copies/ml (200 IU/ml) before the first dose, and the test Patients should receive anti-HBV therapy during the entire study chemotherapy drug treatment period to avoid viral reactivation. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but virus reactivation needs to be closely monitored; active Subjects infected with HCV (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection) ;
- Live vaccine has been vaccinated within 30 days before the first dose (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, it is not allowed to receive live attenuated influenza vaccine for intranasal administration;
- The medical history or disease evidence that may interfere with the test results, prevent the subjects from participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator believes are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenxiang Wang
Changsha, Hunan
Wenxiang Wang, +8613808454225, wangwenxiang@hnca.org.cn
About this study
Official title: PD-1 Monoclonal Antibody Camrelizumab Combined With Albumin Paclitaxel and Platinum for Neoadjuvant Treatment of Adcanced Esophageal Squamous Cell Carcinoma (ESCC): A Single-center, Single-arm Phase II Clinical Study
To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and platinum chemotherapy in the preoperative treatment of locally advanced thoracic esophageal squamous cell carcinoma
Read the detailed description
Primary outcome:
- Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
Secondary outcome:
Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical resection (R0);
Explorative outcome:
To explore the efficacy of ultrasound gastroscopy, PET/CT, peripheral circulating blood tumor cell (CTC) detection and CTC-based immunofluorescence detection of PD-L1 antibody for the treatment of locally advanced ESCC with camrelizumab combined with albumin paclitaxel and platinum and potential biomarkers for predicting the efficacy of camrelizumab, including but not limited to immunohistochemical detection of PD-L1 expression in tumor specimens, T cell receptor (TCR) sequencing analysis in peripheral blood, and esophageal microbiome Analysis, etc.; patients' quality of life
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Camrelizumab, Albumin Paclitaxel, Carboplatin
- Keywords
- PD-1 Checkpoint Inhibitor, Neoadjuvant Therapy, Esophageal Squamous Cell Carcinoma (ESCC)
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab, Albumin Paclitaxel, CarboplatinDrug
Also called SHR1210
Intravenous administration of Camrelizumab (200mg/3weeks); Intravenous administration of albumin paclitaxel (260 mg/m2/3weeks); Intravenous administration of carboplatin (AUC 4/3weeks)
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab, Albumin Paclitaxel, Carboplatin | Experimental | ESCC participants in this study will be given intravenous administration of Camrelizumab (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration.
Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment. Receives: Drug: Camrelizumab, Albumin Paclitaxel, Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
evaluated by researchers based on the RECIST 1.1 standard
Measured: through study completion, an average of 2 year
progression free survival (PFS)
evaluated by researchers based on the RECIST 1.1 standard
Measured: through study completion, an average of 2 year
overall survival (OS)
evaluated by researchers based on the RECIST 1.1 standard
Measured: through study completion, an average of 2 year
Disease control rate(DCR)
evaluated by researchers based on the RECIST 1.1 standard
Measured: through study completion, an average of 2 year
pathologic complete response (pCR)
evaluated by researchers based on the RECIST 1.1 standard
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Model description
- Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of SHR-1210 (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- wangwenxiang@hnca.org.cn wangwenxiang@hnca.org.cn, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767295
- Sponsor's protocol ID
- HNCH-ESCC-001
- Status last verified
- Feb 2021
- First submitted
- 18 Jan 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Monoclonal Antibody Camrelizumab Combined With Albumin Paclitaxel and Platinum for Neoadjuvant Treatment of Adcanced Esophageal Squamous Cell Carcinoma (ESCC): A Single-center, Single-arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04767295
- Acronym / sponsor ID
- HNCH-ESCC-001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- PD-1 Checkpoint Inhibitor, Neoadjuvant Therapy, Esophageal Squamous Cell Carcinoma (ESCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 23 Feb 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.
To evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and platinum chemotherapy in the preoperative treatment of locally advanced thoracic esophageal squamous cell carcinoma
Detailed description
Primary outcome:
- Analysis of prognosis efficacy of patients: pathologic complete response (pCR)
Secondary outcome:
Overall survival(OS), Progressive-free survival(PFS), Disease control rate(DCR), Objective response rate(ORR), and the proportion of subjects who completed all treatments and radical resection (R0);
Explorative outcome:
To explore the efficacy of ultrasound gastroscopy, PET/CT, peripheral circulating blood tumor cell (CTC) detection and CTC-based immunofluorescence detection of PD-L1 antibody for the treatment of locally advanced ESCC with camrelizumab combined with albumin paclitaxel and platinum and potential biomarkers for predicting the efficacy of camrelizumab, including but not limited to immunohistochemical detection of PD-L1 expression in tumor specimens, T cell receptor (TCR) sequencing analysis in peripheral blood, and esophageal microbiome Analysis, etc.; patients' quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients fulfilling Eligibility Criteria will be included in our study. ESCC participants in this study will be given intravenous administration of SHR-1210 (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment.
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab, Albumin Paclitaxel, Carboplatin | Experimental | Drug: Camrelizumab, Albumin Paclitaxel, CarboplatinESCC participants in this study will be given intravenous administration of Camrelizumab (200mg/3w) combined with albumin paclitaxel (260 mg/m2) plus carboplatin chemotherapy. Every three weeks for a cycle of treatment, which will be conducted twice, and minimally invasive surgery within 5-8 weeks after the last administration. Treatments will be administrated until disease progression, unacceptable adverse events (AE), concomitant diseases that hinder continued treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Sign the informed consent form before any trial-related procedures are implemented;
- Age 18-70 years, both men and women;
- pathologically confirmed thoracic esophageal squamous cell carcinoma;
- The clinical staging is T3-4a (potentially resectable) N0-2 (PET/CT or cervical, chest and abdomen CT + intra-esophageal ultrasound staging, except those with N3 stage); T1-2N1-2 can be included in the study, T4b, T1-2N0, carcinoma in situ are all excluded;
- The longitudinal length of the tumor is less than 8cm;
Key exclusion criteria (24 listed)
- Medical history of malignant tumors in other parts, excluding curable non-melanoma skin cancer, radically excised cervical carcinoma in situ, and malignant tumors that have been cured for more than 5 years;
- Pregnant or breast-feeding patients who have fertility but have not taken contraceptive measures;
- Those who are allergic to the study drug camrelizumab, paclitaxel or platinum;
- Previous peripheral neuropathy (whether primary or secondary);
- Severe comorbidities: large-area myocardial infarction, myocardial infarction within 6 months, history of cerebral infarction, heart function ≥ grade III, history of mental illness and severe diabetes, severe pulmonary dysfunction, or other conditions that are not suitable for surgery;
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, Albumin Paclitaxel, CarboplatinAlso: SHR1210Intravenous administration of Camrelizumab (200mg/3weeks); Intravenous administration of albumin paclitaxel (260 mg/m2/3weeks); Intravenous administration of carboplatin (AUC 4/3weeks) | Drug | Camrelizumab, Albumin Paclitaxel, Carboplatin |
Primary outcome
Objective remission rate (ORR)
Time frame: through study completion, an average of 2 year
evaluated by researchers based on the RECIST 1.1 standard
progression free survival (PFS)
Time frame: through study completion, an average of 2 year
evaluated by researchers based on the RECIST 1.1 standard
overall survival (OS)
Time frame: through study completion, an average of 2 year
evaluated by researchers based on the RECIST 1.1 standard
Disease control rate(DCR)
Time frame: through study completion, an average of 2 year
evaluated by researchers based on the RECIST 1.1 standard
pathologic complete response (pCR)
Time frame: through study completion, an average of 2 year
evaluated by researchers based on the RECIST 1.1 standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Yes. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
wangwenxiang@hnca.org.cn wangwenxiang@hnca.org.cn principal investigator
Hunan Cancer Hospital
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, Albumin Paclitaxel, Carboplatin in people with Esophageal Squamous Cell Carcinoma, run by Hunan Cancer 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 14 inclusion and 24 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 23 Feb 2021. 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 Wenxiang Wang (+8613808454225, wangwenxiang@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (ORR) (time frame: through study completion, an average of 2 year). The study lists 5 primary outcomes in all. 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 23 Feb 2021.