Squamous Cell CarcinomaPhase 2NCT03985670
Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
A Phase 2 study testing teripalimab plus chemotherapy and chemotherapy plus teripalimab in people with Squamous Cell Carcinoma and Esophageal Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma, Esophageal Cancer, Perioperative Period
- What is being tested?
- teripalimab plus chemotherapy and chemotherapy plus teripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2019to 30 Apr 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
- Thoracic esophageal squamous cell carcinoma diagnosed by pathology
- no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
- ECOG score 0-1
- clinical stage is stage II, III, and IVa according to AJCC 8.0
- expected lifespan > 3 months
- enough organ function
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- normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
- the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
- no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
- no history of other malignant tumors
- women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
- The patient agrees to participate in the clinical study and sign the Informed Consent Form.
Who cannot join
- suffering from serious infectious diseases within 4 weeks before enrollment;
- patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
- usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
- clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
- severe allergies
- severe mental disorder
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- abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy
- previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc
- other situations evaluated by investigators not meet the enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
Quanli Gao, M.D, +86-371-65587795, gaoquanli2015@126.com
Lingdi Zhao, M.D., +86-371-65587483, lingdizhao@126.com
About this study
Official title: Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
Read the detailed description
The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
- Being tested
- teripalimab plus chemotherapy, chemotherapy plus teripalimab
- Medical subject headings
- Carcinoma, Squamous Cell, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teripalimab plus chemotherapyDrug
Also called teripalimab and chemotherapy given on the same day
teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
chemotherapy plus teripalimabDrug
Also called chemotherapy followed by teripalimab
paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 Receives: Drug: teripalimab plus chemotherapy |
| chemotherapy followed by immunotherapy | Active comparator | paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3 Receives: Drug: chemotherapy plus teripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
the proportion of patients got pathological complete response rate
Measured: two months
Secondary outcomes (2)
occurrence rate of adverse events
the occurrence of adverse events
Measured: three month
disease-free survival rate
the proportion of patients without relapse
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start10 Jul 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Ding, Master, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985670
- Sponsor's protocol ID
- HenanCH immunotherapy001
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing W, Zhao L, Zheng Y, Liu B, Liu X, Li T, Zhang Y, Ma B, Yang Y, Shang Y, Fu X, Liang G, Yuan D, Qu J, Chai X, Zhang H, Wang Z, Lin H, Liu L, Ren X, Zhang J, Gao Q. The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer-A Phase II Study. Front Immunol. 2021 Dec 6;12:772450. doi: 10.3389/fimmu.2021.772450. eCollection 2021.
PubMed 34938292Xing W, Zhao L, Fu X, Liang G, Zhang Y, Yuan D, Li Z, Gao Q, Zheng Y; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma. J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198.
PubMed 33282388
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer
- ClinicalTrials.gov ID
- NCT03985670
- Acronym / sponsor ID
- HenanCH immunotherapy001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 14 Jun 2019 (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 prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
Detailed description
The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: teripalimab plus chemotherapyteripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 |
| chemotherapy followed by immunotherapy | Active comparator | Drug: chemotherapy plus teripalimabpaclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Thoracic esophageal squamous cell carcinoma diagnosed by pathology
- no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
- ECOG score 0-1
- clinical stage is stage II, III, and IVa according to AJCC 8.0
- expected lifespan > 3 months
Key exclusion criteria (9 listed)
- suffering from serious infectious diseases within 4 weeks before enrollment;
- patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
- usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
- clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%
- severe allergies
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 |
|---|---|---|
| teripalimab plus chemotherapyAlso: teripalimab and chemotherapy given on the same dayteripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 | Drug | treatment group |
| chemotherapy plus teripalimabAlso: chemotherapy followed by teripalimabpaclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3 | Drug | chemotherapy followed by immunotherapy |
Primary outcome
Pathological complete response rate
Time frame: two months
the proportion of patients got pathological complete response rate
2 secondary outcomes
occurrence rate of adverse events
Time frame: three month
disease-free survival rate
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 34938292Xing W, Zhao L, Zheng Y, Liu B, Liu X, Li T, Zhang Y, Ma B, Yang Y, Shang Y, Fu X, Liang G, Yuan D, Qu J, Chai X, Zhang H, Wang Z, Lin H, Liu L, Ren X, Zhang J, Gao Q. The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer-A Phase II Study. Front Immunol. 2021 Dec 6;12:772450. doi: 10.3389/fimmu.2021.772450. eCollection 2021.
- Derived from this study: PubMed 33282388Xing W, Zhao L, Fu X, Liang G, Zhang Y, Yuan D, Li Z, Gao Q, Zheng Y; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma. J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198.
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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.
Jing Ding, Master principal investigator
Henan 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 teripalimab plus chemotherapy and chemotherapy plus teripalimab in people with Squamous Cell Carcinoma and Esophageal Cancer, run by Henan 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 12 inclusion and 9 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 Dec 2019. 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 Quanli Gao, Dr. (+86-15038171966, gaoquanli2015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03985670, which also lists 2 linked publications.
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 Dec 2019.