Unresectable Gastric CancerNCT05385809
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer
An observational study of Unresectable Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unresectable Gastric Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2023
- 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: 100 pantients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received immunotherapy prior to surgical resection
Who may be able to join
- Ages: 18-75 Years (concluding 18 and 75 Years)
- Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
- Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
- Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
- Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
- At least 1 measurable lesion by RECIST v1.1 criteria
- ECOG PS: 0-2
- Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle
Who cannot join
- Known Her2 positive
- Patients with incomplete data or other factors affecting the judgment of efficacy and safety
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Cheng Xiangdong, MD, +0086-571-88128041, Chengxd516@126.com
About this study
Official title: A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma
This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.
- Conditions
- Unresectable Gastric Cancer
- Keywords
- Unresectable Gastric Cancer, Conversion Therapy, Immunotherapy, Sintilimab
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conversion rate
Measured: two years
Secondary outcomes (4)
R0 resection rate
Defined as no residue under the microscope after resection
Measured: two years
Major pathological response (MPR)
MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Measured: two years
Overall response rate ( ORR)
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment
Measured: two years
adverse event (AEs)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jun 2022
- Primary completion30 Jul 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, MD, PhD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385809
- Sponsor's protocol ID
- IRB-2022-278
- Status last verified
- Nov 2022
- First submitted
- 17 May 2022
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma
- ClinicalTrials.gov ID
- NCT05385809
- Acronym / sponsor ID
- IRB-2022-278
- Conditions
- Unresectable Gastric Cancer
- Keywords
- Unresectable Gastric Cancer, Conversion Therapy, Immunotherapy, Sintilimab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 May 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 was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 pantients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received immunotherapy prior to surgical resection
Key inclusion criteria (8 listed)
- Ages: 18-75 Years (concluding 18 and 75 Years)
- Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
- Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
- Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
- Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
Key exclusion criteria (2 listed)
- Known Her2 positive
- Patients with incomplete data or other factors affecting the judgment of efficacy and safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical conversion rate
Time frame: two years
4 secondary outcomes
R0 resection rate
Time frame: two years
Major pathological response (MPR)
Time frame: two years
Overall response rate ( ORR)
Time frame: two years
adverse event (AEs)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
Xiangdong Cheng, MD, PhD principal investigator
Zhejiang Cancer Hospital
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 Unresectable Gastric Cancer, run by Zhejiang 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 8 inclusion and 2 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 9 Nov 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 Pengfei Yu, MD, PhD (86-571-88128031, ypfzmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical conversion rate (time frame: two years). 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 9 Nov 2022.