Esophageal Squamous Cell CarcinomaSPEEDNCT05561699
Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer
A study testing Penpulimab Combined With CRT in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Penpulimab Combined With CRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- 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
- Resectable t2,3,4an0-1-2m0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology;
- Without any systematic anti-tumor treatment;
- ECOG 0-1;
- ANC≥ 1.5×109/L;
- PLT≥ 75×109/L;
- HB≥ 8.0 g/dL;
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- TBIL ≤ 1.5´ ULN;
- ALT and AST ≤ 2.5´ULN;
- Cr ≤ 1.5´ULN or CCr ≥ 60ml/min;
- Urine protein < +, if urine protein + then the total protein in 24 hours must be <500mg;
- Blood glucose is within the normal range and / or patients with diabetes are in treatment, but blood glucose is controlled in a stable state;
- FEV1 ≥ 2L; If the baseline FEV1 is less than 2L, it is estimated that the FEV1 after surgery is greater than 800ml；
- No myocardial infarction within 1 year; No unstable angina pectoris; No symptomatic severe arrhythmia; No cardiac insufficiency；
- There are no serious complications or other major diseases that have not been cured；
- Thoracic surgeons judge those who can tolerate the operation；
- Female subjects with fertility and male subjects with partners of childbearing age need to use a medically approved contraceptive measure during the study treatment and at least 6 months after the last chemotherapy；
- The subjects voluntarily joined the study and signed the informed consent form
Who cannot join
- Received any kind of systematic anti-tumor treatment before the first use of the study drug；
- At the same time, another clinical study will be included, unless it is an observational (non intervention) clinical study；
- Subjects who need to be given corticosteroids (more than 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug；
- Have been vaccinated with tumor vaccine or have been vaccinated with live vaccine within 4 weeks before administration；
- Have a history of active autoimmune diseases and autoimmune diseases; Except for patients who have recovered from childhood asthma / allergy and do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; Use a stable dose of insulin for type I diabetes；
- Serious interference occurred within 4 weeks before the first use of the study drug (CTC AE>2); Baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics；
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- Have a history of interstitial lung disease；
- The subjects had active hepatitis B (HBV DNA ≥ 2000 IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of the analysis method);
- Pregnant or lactating women;
- There are serious complications or other major diseases that have not been cured;
- Patients judged by thoracic surgeons to be intolerant of surgery
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Jian Wang, MD, 0086-13816101686, wang.jian3@zs-hospital.sh.cn
About this study
Official title: Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center，Exploratory Study
This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Penpulimab Combined With CRT
- 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.
Penpulimab Combined With CRTDrug
- Penpulimab: 200mg, intravenous infusion, once every two weeks. After completing two courses of CRT, continue to send Penpulimab 200mg every two weeks on the first and 14th days after the completion of CRT, two courses of treatment, a total of four courses.
- Radiotherapy 40gy/20fx, once a day from Monday to Friday, completed in 4 weeks;
- PC regimen: Paclitaxel 50mg/m2, intravenous drip, carboplatin AUC=2mg/ml/min, intravenous drip, once a week during radiotherapy, a total of 4 courses, the specific time is D1, 8, 15, 22 days after the beginning of radiotherapy.
- Gastrointestinal reactions such as nausea and vomiting should be routinely prevented before chemotherapy. Dexamethasone 10mg should be used 30 ~ 60 minutes before paclitaxel, and intramuscular injection should be stopped immediately in case of drug or infusion reactions.
| Study group | Role | What they receive |
|---|---|---|
| Penpulimab Combined With Chemoradiotherapy(CRT) | Experimental | Not described Receives: Drug: Penpulimab Combined With CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission（pCR）rate
Proportion of subjects who achieved pathological complete remission (PCR)，PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery.
Measured: 3 to 4 months
safety（AE or SAE）
Incidence of adverse events or serious adverse events
Measured: 2 to 3 years from baseline
Secondary outcomes (5)
Tumor regression grade（TRG）
Evaluation of the focus of primary tumor after radiotherapy and chemotherapy
Measured: 3 to 4 months
R0 resection rate
Proportion of subjects reaching R0 resection. resection was defined as no tumor cells remained within 1mm of the two cutting edges of the esophageal cancer lesions removed during the operation.
Measured: 3 to 4 months
Event free survival（EFS）
Date of first administration to date of first recording of relevant events
Measured: 2 to 3 years from baseline
Overall survival（OS）
Date of first administration to date of death due to any cause
Measured: 2 to 3 years from baseline
Disease free survival（DFS）
Date from the operation to the first recording of relevant events
Measured: 2 to 3 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start28 Sep 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (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.
- More trials run by Shanghai Zhongshan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561699
- Sponsor's protocol ID
- B2022-143R2
- Acronym
- SPEED
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2022
- Last updated
- 30 Sep 2022
- 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 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center，Exploratory Study
- ClinicalTrials.gov ID
- NCT05561699
- Acronym / sponsor ID
- SPEED / B2022-143R2
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 28 Sep 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Sep 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.
This study used an open single center study design to observe the efficacy and safety of Penpulimab combined with Chemoradiotherapy(CRT) in preoperative T2,3,4aN0-1-2M0 esophageal squamous cell carcinoma (ESCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penpulimab Combined With Chemoradiotherapy(CRT) | Experimental | Drug: Penpulimab Combined With CRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Resectable t2,3,4an0-1-2m0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology;
- Without any systematic anti-tumor treatment;
- ECOG 0-1;
- ANC≥ 1.5×109/L;
- PLT≥ 75×109/L;
Key exclusion criteria (11 listed)
- Received any kind of systematic anti-tumor treatment before the first use of the study drug；
- At the same time, another clinical study will be included, unless it is an observational (non intervention) clinical study；
- Subjects who need to be given corticosteroids (more than 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug；
- Have been vaccinated with tumor vaccine or have been vaccinated with live vaccine within 4 weeks before administration；
- Have a history of active autoimmune diseases and autoimmune diseases; Except for patients who have recovered from childhood asthma / allergy and do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; Use a stable dose of insulin for type I diabetes；
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 |
|---|---|---|
| Penpulimab Combined With CRT1. Penpulimab: 200mg, intravenous infusion, once every two weeks. After completing two courses of CRT, continue to send Penpulimab 200mg every two weeks on the first and 14th days after the completion of CRT, two courses of treatment, a total of four courses. 2. Radiotherapy 40gy/20fx, once a day from Monday to Friday, completed in 4 weeks; 3. PC regimen: Paclitaxel 50mg/m2, intravenous drip, carboplatin AUC=2mg/ml/min, intravenous drip, once a week during radiotherapy, a total of 4 courses, the specific time is D1, 8, 15, 22 days after the beginning of radiotherapy. 4. Gastrointestinal reactions such as nausea and vomiting should be routinely prevented before chemotherapy. Dexamethasone 10mg should be used 30 ~ 60 minutes before paclitaxel, and intramuscular injection should be stopped immediately in case of drug or infusion reactions. | Drug | Penpulimab Combined With Chemoradiotherapy(CRT) |
Primary outcome
pathological complete remission（pCR）rate
Time frame: 3 to 4 months
Proportion of subjects who achieved pathological complete remission (PCR)，PCR was defined as the microscopic absence of tumor cells in the pathological evaluation of excised esophageal cancer lesions and regional lymph node samples after surgery.
safety（AE or SAE）
Time frame: 2 to 3 years from baseline
Incidence of adverse events or serious adverse events
5 secondary outcomes
Tumor regression grade（TRG）
Time frame: 3 to 4 months
R0 resection rate
Time frame: 3 to 4 months
Event free survival（EFS）
Time frame: 2 to 3 years from baseline
Overall survival（OS）
Time frame: 2 to 3 years from baseline
Disease free survival（DFS）
Time frame: 2 to 3 years from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
Jian Wang, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penpulimab Combined With CRT in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan 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 17 inclusion and 11 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 30 Sep 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.
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 Yang Qian, MD (0086-13817929371, qy19792006@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete remission（pCR）rate (time frame: 3 to 4 months). The study lists 2 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 30 Sep 2022.