Gastric AdenocarcinomaNCT05001360
Study of FMT Combined With Nivolumab in Gastric Cancer
A study testing XBI-302 + Nivolumab in people with Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma, Esophagus Adenocarcinoma
- What is being tested?
- XBI-302 + Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Nov 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in this study and provide written informed consent
- Age ≥ 18 years and ≤70 years, male or female
- Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies
- Able and willing to provide tumor tissue
- At least one measurable extracranial target lesion according to iRECIST
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy ≥3 months
Who cannot join
- History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin
- Had systemic diseases that were difficult to control within 4 weeks prior to screening
- History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy
- History of coagulation disorders
- Mechanical or paralytic obstruction of the gastrointestinal tract
- Anticipated to receive a great number of antibiotics during study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
This study is a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
Read the detailed description
The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
During treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.
- Being tested
- XBI-302 + Nivolumab
- Medical subject headings
- Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XBI-302 + NivolumabDrug
Also called FMT + PD-1 inhibitor
After gut preparation, a single dose of FMT will be performed via oral administration. Subsequently, nine combined treatment cycles that composed of anti-PD-1 infusions (Nivolumab at 240 mg, q2w) and additional FMT capsules, and 3 single treatment cycles of anti-PD-1 infusions will be administered.
| Study group | Role | What they receive |
|---|---|---|
| XBI-302 + Nivolumab | Experimental | FMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks. Receives: Drug: XBI-302 + Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
Measured: 24 weeks
Secondary outcomes (8)
Disease control rate
iCR + iPR + iSD rate according to iRECIST criteria
Measured: 6, 12, 18 weeks
Objective response rate
iCR + iPR rate according to iRECIST criteria
Measured: 24 weeks
Changes of intestinal microbiota characteristics between responders and non-responders
To compare the change of intestinal microbiota characteristics between responders and non-responders
Measured: 24 weeks
Changes of related immune cells in peripheral blood between responders and non-responders
To compare the change of related immune cells in peripheral blood between responders and non-responders
Measured: 12 weeks
Change of CD8+T cell counts in tumor tissue between responders and non-responders
To compare the change of CD8+T cell counts in tumor tissue between responders and non-responders
Measured: 6 weeks
Change of CD8+T cell counts in intestinal tissue between responders and non-responders
To compare the change of CD8+T cell counts in intestinal tissue between responders and non-responders
Measured: 6 weeks
Incidence and severity of AEs that related to XBI-302
Rate of adverse events and their severity that are determined to be related to XBI-302
Measured: 24 weeks
Incidence and severity of immune related AEs
Rate and severity of irAEs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: We could not get the IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001360
- Sponsor's protocol ID
- SYLT-022
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of FMT Capsules XBI-302 Combined With Nivolumab in the Treatment of Anti-PD-1/L1 Resistant Gastric Cancer
- ClinicalTrials.gov ID
- NCT05001360
- Acronym / sponsor ID
- SYLT-022
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We could not get the IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 11 Aug 2021 (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 a single-arm, single center study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
Detailed description
The primary purpose of this single-arm, open-label, single center trial is to evaluate the efficacy and safety of XBI-302 combined with Nivolumab in the treatment of anti-PD-1/L1 resistant gastric cancer.
During treatment period, all eligible subjects will receive XBI-302 with Nivolumab following gut preparation. The imaging evaluation of efficacy will be performed every 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XBI-302 + Nivolumab | Experimental | Drug: XBI-302 + NivolumabFMT capsules XBI-302 will be administered orally every two weeks for 12 weeks and then every four weeks for 12 weeks. Nivolumab will be intravenously infused every two weeks for 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily participate in this study and provide written informed consent
- Age ≥ 18 years and ≤70 years, male or female
- Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma and lower esophagus adenocarcinoma that are resistant to anti-PD-1/L1 antibodies
- Able and willing to provide tumor tissue
- At least one measurable extracranial target lesion according to iRECIST
Key exclusion criteria (6 listed)
- History of other primary malignancies within 5 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin
- Had systemic diseases that were difficult to control within 4 weeks prior to screening
- History of anti-PD-1 antibodies related adverse reactions that led to the permanent withdrawal of anti-PD-1 therapy
- History of coagulation disorders
- Mechanical or paralytic obstruction of the gastrointestinal tract
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 |
|---|---|---|
| XBI-302 + NivolumabAlso: FMT + PD-1 inhibitorAfter gut preparation, a single dose of FMT will be performed via oral administration. Subsequently, nine combined treatment cycles that composed of anti-PD-1 infusions (Nivolumab at 240 mg, q2w) and additional FMT capsules, and 3 single treatment cycles of anti-PD-1 infusions will be administered. | Drug | XBI-302 + Nivolumab |
Primary outcome
Disease control rate
Time frame: 24 weeks
iCR + iPR + iSD rate according to iRECIST criteria
8 secondary outcomes
Disease control rate
Time frame: 6, 12, 18 weeks
Objective response rate
Time frame: 24 weeks
Changes of intestinal microbiota characteristics between responders and non-responders
Time frame: 24 weeks
Changes of related immune cells in peripheral blood between responders and non-responders
Time frame: 12 weeks
Change of CD8+T cell counts in tumor tissue between responders and non-responders
Time frame: 6 weeks
Change of CD8+T cell counts in intestinal tissue between responders and non-responders
Time frame: 6 weeks
Incidence and severity of AEs that related to XBI-302
Time frame: 24 weeks
Incidence and severity of immune related AEs
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Gastric Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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?
A study testing XBI-302 + Nivolumab in people with Gastric Adenocarcinoma and Esophagogastric Junction Adenocarcinoma, run by Fujian 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 7 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: withdrawn, as of the sponsor's last update on 27 Oct 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Disease control rate (time frame: 24 weeks). 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 27 Oct 2021.