Resectable Esophageal Squamous Cell CarcinomaNCT06475196
Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC
An observational study of Resectable Esophageal Squamous Cell Carcinoma, run by Tang-Du Hospital at 1 site in China.
Trial summary
This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sintilimab (PD-1 inhibitor)
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2024to 20 Jun 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
Study population: This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer
Who may be able to join
- Preoperative gastroscopy showed that the main body of the tumor was located.
- Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
- Signed informed consent and met all the inclusion criteria of this study. 4）aged 18~75 years old 5）ECOG PS score of 0-1;
Who cannot join
- prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
- .previous systemic therapy;
- current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
- presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
- the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital of the Fourth Millitary Medical University
Xi'an, Shaanxi, 710000
About this study
Official title: The Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma
This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.
- Being tested
- Sintilimab (PD-1 inhibitor)
- Keywords
- neoadjuvant therapy, PD-1 inhibitor, resectable esophageal squamous cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab (PD-1 inhibitor)Drug
to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group A | sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles Receives: Drug: Sintilimab (PD-1 inhibitor) | |
| Group B | sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle Receives: Drug: Sintilimab (PD-1 inhibitor) | |
| Group C | sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles Receives: Drug: Sintilimab (PD-1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete pathologic response (pCR)
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Measured: 3 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tang-Du 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475196
- Sponsor's protocol ID
- IIT202405-09
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06475196
- Acronym / sponsor ID
- IIT202405-09
- Keywords
- neoadjuvant therapy, PD-1 inhibitor, resectable esophageal squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 26 Jun 2024 (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 is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Sintilimab (PD-1 inhibitor)sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles |
| Group B | – | Drug: Sintilimab (PD-1 inhibitor)sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle |
| Group C | – | Drug: Sintilimab (PD-1 inhibitor)sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer
Key inclusion criteria (3 listed)
- Preoperative gastroscopy showed that the main body of the tumor was located.
- Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
- Signed informed consent and met all the inclusion criteria of this study. 4）aged 18~75 years old 5）ECOG PS score of 0-1;
Key exclusion criteria (5 listed)
- prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
- .previous systemic therapy;
- current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
- presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
- the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -
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 |
|---|---|---|
| Sintilimab (PD-1 inhibitor)to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. | Drug | Group A, Group B, Group C |
Primary outcome
complete pathologic response (pCR)
Time frame: 3 mouths
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Esophageal Squamous Cell Carcinoma, run by Tang-Du 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 3 inclusion and 5 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 26 Jun 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete pathologic response (pCR) (time frame: 3 mouths). 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 26 Jun 2024.