Esophageal Squamous Cell CarcinomaNCT05199649
Correlation Between the Efficacy of Neoadjuvant Chemotherapy Combined With Immunotherapy of Operable Thoracic Esophageal Squamous Cell Carcinoma and the Metabolites of Intestinal Flora
A study testing SintilimabCombined With Chemotherapy in people with Esophageal Squamous Cell Carcinoma and Intestinal Flora, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study collects stool, blood, and tumor tissue samples from patients with locally advanced esophageal cancer after receiving Sintilimab and chemotherapy to explore the efficacy and intestinal microbes of chemotherapy combined with neoadjuvant immunotherapy for locally advanced operable thoracic esophageal squamous… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Intestinal Flora
- What is being tested?
- SintilimabCombined With Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Jun 2023
- 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
- 1) Age ≥18 years old and ≤75 years old; 2) Patients with stage I~III thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ECOG PS score is 0 or 1; 4) It has sufficient organ and bone marrow function.
Who cannot join
- Refuse to participate;
- Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;
- Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
- Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
- Have received systemic systemic treatment with anti-tumor indications Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;
- Have used immunosuppressive drugs within 1 week before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day prednisone Or equivalent doses of other glucocorticoids), or use hormones to prevent allergy to contrast agents.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215000
Jun Zhao, 86-0512-67972216, zhaojia0327@126.com
About this study
This study collects stool, blood, and tumor tissue samples from patients with locally advanced esophageal cancer after receiving Sintilimab and chemotherapy to explore the efficacy and intestinal microbes of chemotherapy combined with neoadjuvant immunotherapy for locally advanced operable thoracic esophageal squamous cell carcinoma The main purpose is the relationship between its metabolites, and it will also explore the changes of intestinal flora diversity and metabolites before and after esophageal squamous cell carcinoma chemotherapy combined with immune neoadjuvant therapy
- Being tested
- SintilimabCombined With Chemotherapy
- 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.
SintilimabCombined With ChemotherapyDrug
Sintilimab and chemotherapy are carried out at the same time for every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm Sintilimab | Experimental | Sintilimab Combined With Chemotherapy Receives: Drug: SintilimabCombined With Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Species and abundance of gut microbiota
Alpha-diversity of samples, that measures both the richness and diversity of species within a group, was calculated on taxa that were observed at least once.
Beta-diversity, that measures the differences in microbiome composition between groups.
Measured: 2 year
Secondary outcomes (1)
Explore the changes of intestinal flora and metabolomics before and after medication
Discovery of gut microbes and metabolic markers that can predict the efficacy of chemotherapy combined with neoadjuvant immunotherapy for esophageal squamous cell carcinoma
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199649
- Sponsor's protocol ID
- 20211211
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavelle A, Sokol H. Gut microbiota-derived metabolites as key actors in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Apr;17(4):223-237. doi: 10.1038/s41575-019-0258-z. Epub 2020 Feb 19.
PubMed 32076145Wilson AJ, Chueh AC, Togel L, Corner GA, Ahmed N, Goel S, Byun DS, Nasser S, Houston MA, Jhawer M, Smartt HJ, Murray LB, Nicholas C, Heerdt BG, Arango D, Augenlicht LH, Mariadason JM. Apoptotic sensitivity of colon cancer cells to histone deacetylase inhibitors is mediated by an Sp1/Sp3-activated transcriptional program involving immediate-early gene induction. Cancer Res. 2010 Jan 15;70(2):609-20. doi: 10.1158/0008-5472.CAN-09-2327. Epub 2010 Jan 12.
PubMed 20068171Mager LF, Burkhard R, Pett N, Cooke NCA, Brown K, Ramay H, Paik S, Stagg J, Groves RA, Gallo M, Lewis IA, Geuking MB, McCoy KD. Microbiome-derived inosine modulates response to checkpoint inhibitor immunotherapy. Science. 2020 Sep 18;369(6510):1481-1489. doi: 10.1126/science.abc3421. Epub 2020 Aug 13.
PubMed 32792462Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
PubMed 32887946Ocvirk S, Wilson AS, Posma JM, Li JV, Koller KR, Day GM, Flanagan CA, Otto JE, Sacco PE, Sacco FD, Sapp FR, Wilson AS, Newton K, Brouard F, DeLany JP, Behnning M, Appolonia CN, Soni D, Bhatti F, Methe B, Fitch A, Morris A, Gaskins HR, Kinross J, Nicholson JK, Thomas TK, O'Keefe SJD. A prospective cohort analysis of gut microbial co-metabolism in Alaska Native and rural African people at high and low risk of colorectal cancer. Am J Clin Nutr. 2020 Feb 1;111(2):406-419. doi: 10.1093/ajcn/nqz301.
PubMed 31851298
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Efficacy of Neoadjuvant Chemotherapy Combined With Immunotherapy of Operable Thoracic Esophageal Squamous Cell Carcinoma and the Metabolites of Intestinal Flora
- ClinicalTrials.gov ID
- NCT05199649
- Acronym / sponsor ID
- 20211211
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Jan 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 collects stool, blood, and tumor tissue samples from patients with locally advanced esophageal cancer after receiving Sintilimab and chemotherapy to explore the efficacy and intestinal microbes of chemotherapy combined with neoadjuvant immunotherapy for locally advanced operable thoracic esophageal squamous cell carcinoma The main purpose is the relationship between its metabolites, and it will also explore the changes of intestinal flora diversity and metabolites before and after esophageal squamous cell carcinoma chemotherapy combined with immune neoadjuvant therapy
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm Sintilimab | Experimental | Drug: SintilimabCombined With ChemotherapySintilimab Combined With Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age ≥18 years old and ≤75 years old; 2) Patients with stage I~III thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ECOG PS score is 0 or 1; 4) It has sufficient organ and bone marrow function.
Key exclusion criteria (6 listed)
- Refuse to participate;
- Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;
- Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug;
- Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
- Have received systemic systemic treatment with anti-tumor indications Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;
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 |
|---|---|---|
| SintilimabCombined With ChemotherapySintilimab and chemotherapy are carried out at the same time for every 3 weeks | Drug | Arm Sintilimab |
Primary outcome
Species and abundance of gut microbiota
Time frame: 2 year
Alpha-diversity of samples, that measures both the richness and diversity of species within a group, was calculated on taxa that were observed at least once. Beta-diversity, that measures the differences in microbiome composition between groups.
1 secondary outcome
Explore the changes of intestinal flora and metabolomics before and after medication
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Results publication: PubMed 32076145Lavelle A, Sokol H. Gut microbiota-derived metabolites as key actors in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Apr;17(4):223-237. doi: 10.1038/s41575-019-0258-z. Epub 2020 Feb 19.
- Results publication: PubMed 20068171Wilson AJ, Chueh AC, Togel L, Corner GA, Ahmed N, Goel S, Byun DS, Nasser S, Houston MA, Jhawer M, Smartt HJ, Murray LB, Nicholas C, Heerdt BG, Arango D, Augenlicht LH, Mariadason JM. Apoptotic sensitivity of colon cancer cells to histone deacetylase inhibitors is mediated by an Sp1/Sp3-activated transcriptional program involving immediate-early gene induction. Cancer Res. 2010 Jan 15;70(2):609-20. doi: 10.1158/0008-5472.CAN-09-2327. Epub 2010 Jan 12.
- Results publication: PubMed 32792462Mager LF, Burkhard R, Pett N, Cooke NCA, Brown K, Ramay H, Paik S, Stagg J, Groves RA, Gallo M, Lewis IA, Geuking MB, McCoy KD. Microbiome-derived inosine modulates response to checkpoint inhibitor immunotherapy. Science. 2020 Sep 18;369(6510):1481-1489. doi: 10.1126/science.abc3421. Epub 2020 Aug 13.
- Results publication: PubMed 32887946Fan Y, Pedersen O. Gut microbiota in human metabolic health and disease. Nat Rev Microbiol. 2021 Jan;19(1):55-71. doi: 10.1038/s41579-020-0433-9. Epub 2020 Sep 4.
- Results publication: PubMed 31851298Ocvirk S, Wilson AS, Posma JM, Li JV, Koller KR, Day GM, Flanagan CA, Otto JE, Sacco PE, Sacco FD, Sapp FR, Wilson AS, Newton K, Brouard F, DeLany JP, Behnning M, Appolonia CN, Soni D, Bhatti F, Methe B, Fitch A, Morris A, Gaskins HR, Kinross J, Nicholson JK, Thomas TK, O'Keefe SJD. A prospective cohort analysis of gut microbial co-metabolism in Alaska Native and rural African people at high and low risk of colorectal cancer. Am J Clin Nutr. 2020 Feb 1;111(2):406-419. doi: 10.1093/ajcn/nqz301.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SintilimabCombined With Chemotherapy in people with Esophageal Squamous Cell Carcinoma and Intestinal Flora, run by The First Affiliated Hospital of Soochow 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 1 inclusion and 6 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 20 Jan 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 Jun Zhao (86-0512-67972216, zhaojia0327@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Species and abundance of gut microbiota (time frame: 2 year). 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 NCT05199649, which also lists 5 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 20 Jan 2022.