Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT04888403
Exploring the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Toripalimab+Nedaplatin+Albumin Paclitaxel in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally and Advanced Esophageal Squamous Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Toripalimab+Nedaplatin+Albumin Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 20 Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age ≥18 years old and ≤70 years old; 2) Pathologically diagnosed thoracic esophageal squamous cell carcinoma (the midpoint of the upper and lower edges of the esophageal primary lesion is ≥25cm from the incisor); 3) There is no distant metastasis by imaging examination, and the esophageal cancer can be resected or potentially resectable after the expert consultation of thoracic surgery. The clinical stage is cT1-T2N1-N2/T3-4aN0-2M0 Ⅱ-IVA patients (AJCC 8th edition cTNM staging); 4) ECOG score 0-1 points; 5) Have not received anti-tumor treatment in the past; 6) Expected survival period> 6 months; 7) The main organ function meets the following criteria:
- Blood routine examination meets the following criteria:
- White blood cell (WBC) ≥3×109/L,Neutrophil count ≥ 1.5 x 109 / L,Platelet ≥ 75 x 109 / L,Hemoglobin ≥ 10.0 g / dL;
- Liver function:
- total bilirubin (TBIL) ≤ 2ULN,Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value;
- Renal function:
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- creatinine clearance (cCr) ≥ 60 ml/min, creatinine (Cr) ≤ 1.5 upper limit of normal (ULN);
- Heart function:
- no heart disease or coronary heart disease, patients with heart function 1-2; The blood pressure of hypertensive patients should be controlled within the normal range by using antihypertensive drugs; 8)The fasting blood sugar of diabetic patients should be controlled at ≤8mmol/L through hypoglycemic drugs; 9)There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation or other diseases that require continuous hormone therapy); 10)No history of other malignant tumors; The patient himself agreed to participate in this clinical study and signed the "Informed Consent".
Who cannot join
- 1)The patient has previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.) 2) The patient has or is expected to have an obvious risk of esophageal perforation, fistula and massive bleeding; 3) Exclude subjects who have previously suffered from other malignant tumors, unless they have achieved complete elimination at least 5 years before entering the study, and no additional treatment is required or expected during the study period (exceptions include but are not limited to basal or squamous cells) Skin cancer, superficial bladder cancer or carcinoma in situ of prostate, cervix or breast); 4)Subjects with known or suspected active autoimmune diseases. It is allowed to include type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (eg, vitiligo, psoriasis, or hair loss), or in the absence of external triggers, it is not expected Subjects with relapsed conditions; 5)Clinically obvious cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention within 6 months before enrollment 、Left ventricular ejection fraction <50%, or other patients who are not expected to tolerate chemotherapy and radiotherapy; 6)Subjects suffering from conditions requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the administration of the study drug. In the absence of active autoimmune diseases, use inhaled or topical steroids and adrenal replacement steroids with an equivalent dose of> 10 mg daily prednisone; 7)Subjects with symptoms or interstitial lung diseases that may interfere with the detection or treatment of suspected drug-related lung toxicity; 8)Those who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs that target T cell costimulation or checkpoint pathways as specific targets treatment; 9)All toxicities (except for kidney disease, neuropathy, hearing loss, hair loss, and fatigue) attributable to previous anti-cancer treatments must be restored to level 1 (NCI CTCAE 5th Edition) or baseline before the study drug is administered. Subjects with toxicity that can be attributed to previous anti-cancer treatments that are not expected to be relieved and lead to long-lasting sequelae (eg, peripheral neuropathy that occurs after platinum-containing treatment) are allowed to be included in the study. Peripheral neuropathy must be relieved to level 2 (NCI CTCAE 5th edition); 10)According to the opinion of the investigator, any serious or uncontrolled medical disease or active infection that may increase research participation, research drug administration related risks, or damage the subject's ability to receive the treatment of the trial protocol; 11)Known human immunodeficiency virus (HIV) test positive history or known suffering from acquired immunodeficiency syndrome (AIDS); 12)Subjects who received live vaccine/attenuated vaccine within 30 days after receiving the first treatment; 13)Patients with active viral hepatitis B or C viral hepatitis. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive at the same time; 14)History of allergies or hypersensitivity to study drug components, and history of severe hypersensitivity to any monoclonal antibody; 15)Other researchers evaluated those who did not meet the enrollment conditions.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Hennan, 450052
Feng Wang, 13938244776, fengw010@163.com
About this study
Official title: A Prospective Study on the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally and Advanced Esophageal Squamous Cell Carcinoma
Read the detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal squamous cell carcinoma.
- Being tested
- Toripalimab+Nedaplatin+Albumin Paclitaxel
- Keywords
- locally advanced Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab+Nedaplatin+Albumin PaclitaxelDrug
Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles.
Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy.
Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab combined with neoadjuvant radiotherapy and chemotherapy Single arm study | Experimental | Induction period:
Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles.
Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy. Receives: Drug: Toripalimab+Nedaplatin+Albumin Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response(pCR)
defined as the absence of any viable tumor at the time of surgical resection,as assessed by central and local pathology laboratory
Measured: At time of surgery
Secondary outcomes (4)
Major Patholgical Response(MPR)
defined as ≤ 10% residual viable tumor at the time of surgical resection,as assessed by central and local pathology laboratory
Measured: At time of surgery
Disease-Free Survival
Time after R0 resection to disease recurrence or death
Measured: up to 2 years
R0 resection rate
R0 is no residue under the microscope after excision
Measured: At time of surgery
postoperative complications rate
Complication refers to the occurrence of another or several diseases related to the treatment of this disease during the treatment of a certain disease
Measured: up to 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start31 Dec 2021 (estimated)
- Primary completion20 Jul 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Feng Wang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888403
- Sponsor's protocol ID
- FQX-006
- Status last verified
- Aug 2021
- First submitted
- 13 May 2021
- Last updated
- 23 Aug 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 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Safety and Effectiveness of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04888403
- Acronym / sponsor ID
- FQX-006
- Keywords
- locally advanced Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 20 Jul 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 17 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.
The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy in the Locally and Advanced Esophageal Squamous Cell Carcinoma
Detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of Toripalimab Combined With Neoadjuvant Radiotherapy and Chemotherapy for locally advanced esophageal 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 |
|---|---|---|
| Toripalimab combined with neoadjuvant radiotherapy and chemotherapy Single arm study | Experimental | Drug: Toripalimab+Nedaplatin+Albumin PaclitaxelInduction period: Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles. Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1) Age ≥18 years old and ≤70 years old; 2) Pathologically diagnosed thoracic esophageal squamous cell carcinoma (the midpoint of the upper and lower edges of the esophageal primary lesion is ≥25cm from the incisor); 3) There is no distant metastasis by imaging examination, and the esophageal cancer can be resected or potentially resectable after the expert consultation of thoracic surgery. The clinical stage is cT1-T2N1-N2/T3-4aN0-2M0 Ⅱ-IVA patients (AJCC 8th edition cTNM staging); 4) ECOG score 0-1 points; 5) Have not received anti-tumor treatment in the past; 6) Expected survival period> 6 months; 7) The main organ function meets the following criteria:
- White blood cell (WBC) ≥3×109/L,Neutrophil count ≥ 1.5 x 109 / L,Platelet ≥ 75 x 109 / L,Hemoglobin ≥ 10.0 g / dL;
- total bilirubin (TBIL) ≤ 2ULN,Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value;
- creatinine clearance (cCr) ≥ 60 ml/min, creatinine (Cr) ≤ 1.5 upper limit of normal (ULN);
- no heart disease or coronary heart disease, patients with heart function 1-2; The blood pressure of hypertensive patients should be controlled within the normal range by using antihypertensive drugs; 8)The fasting blood sugar of diabetic patients should be controlled at ≤8mmol/L through hypoglycemic drugs; 9)There are no other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation or other diseases that require continuous hormone therapy); 10)No history of other malignant tumors; The patient himself agreed to participate in this clinical study and signed the "Informed Consent".
Key exclusion criteria (1 listed)
- 1)The patient has previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.) 2) The patient has or is expected to have an obvious risk of esophageal perforation, fistula and massive bleeding; 3) Exclude subjects who have previously suffered from other malignant tumors, unless they have achieved complete elimination at least 5 years before entering the study, and no additional treatment is required or expected during the study period (exceptions include but are not limited to basal or squamous cells) Skin cancer, superficial bladder cancer or carcinoma in situ of prostate, cervix or breast); 4)Subjects with known or suspected active autoimmune diseases. It is allowed to include type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (eg, vitiligo, psoriasis, or hair loss), or in the absence of external triggers, it is not expected Subjects with relapsed conditions; 5)Clinically obvious cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention within 6 months before enrollment 、Left ventricular ejection fraction <50%, or other patients who are not expected to tolerate chemotherapy and radiotherapy; 6)Subjects suffering from conditions requiring systemic treatment with corticosteroids (>10 mg daily prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the administration of the study drug. In the absence of active autoimmune diseases, use inhaled or topical steroids and adrenal replacement steroids with an equivalent dose of> 10 mg daily prednisone; 7)Subjects with symptoms or interstitial lung diseases that may interfere with the detection or treatment of suspected drug-related lung toxicity; 8)Those who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or drugs that target T cell costimulation or checkpoint pathways as specific targets treatment; 9)All toxicities (except for kidney disease, neuropathy, hearing loss, hair loss, and fatigue) attributable to previous anti-cancer treatments must be restored to level 1 (NCI CTCAE 5th Edition) or baseline before the study drug is administered. Subjects with toxicity that can be attributed to previous anti-cancer treatments that are not expected to be relieved and lead to long-lasting sequelae (eg, peripheral neuropathy that occurs after platinum-containing treatment) are allowed to be included in the study. Peripheral neuropathy must be relieved to level 2 (NCI CTCAE 5th edition); 10)According to the opinion of the investigator, any serious or uncontrolled medical disease or active infection that may increase research participation, research drug administration related risks, or damage the subject's ability to receive the treatment of the trial protocol; 11)Known human immunodeficiency virus (HIV) test positive history or known suffering from acquired immunodeficiency syndrome (AIDS); 12)Subjects who received live vaccine/attenuated vaccine within 30 days after receiving the first treatment; 13)Patients with active viral hepatitis B or C viral hepatitis. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive at the same time; 14)History of allergies or hypersensitivity to study drug components, and history of severe hypersensitivity to any monoclonal antibody; 15)Other researchers evaluated those who did not meet the enrollment conditions.
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 |
|---|---|---|
| Toripalimab+Nedaplatin+Albumin PaclitaxelToripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy. Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel | Drug | Toripalimab combined with neoadjuvant radiotherapy and chemotherapy Single arm study |
Primary outcome
Pathologic Complete Response(pCR)
Time frame: At time of surgery
defined as the absence of any viable tumor at the time of surgical resection,as assessed by central and local pathology laboratory
4 secondary outcomes
Major Patholgical Response(MPR)
Time frame: At time of surgery
Disease-Free Survival
Time frame: up to 2 years
R0 resection rate
Time frame: At time of surgery
postoperative complications rate
Time frame: up to 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 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.
Feng Wang principal investigator
The First Affiliated Hospital of Zhengzhou University
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 Toripalimab+Nedaplatin+Albumin Paclitaxel in people with Locally Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou 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 9 inclusion and 1 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 Aug 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 Feng Wang (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response(pCR) (time frame: At time of surgery). 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 Aug 2021.