Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric AdenocarcinomaPhase 2NCT05163483
Tucidinostat Plus PD-1 Inhibitor and Bevacizumab for Advanced Esophagus Cancer, AEG, Gastric Cancer
A Phase 2 study testing Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab in people with Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma, run by Ruihua Xu at 1 site in China.
Trial summary
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma
- What is being tested?
- Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Dec 2025
- Phase
- Phase 2
- 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
- Age ≥18 years, ≤ 75 years
- Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.
- Can provide at least 5 pieces of pathological section or fresh tumor tissue
- Eastern Collaborative Oncology Group (ECOG) ≤ 1.
- ≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).
- Patients who have previously used PD-1 antibodies, PD-L1 antibodies, PD-L2 antibodies, or CTLA-4 antibodies (or any other antibodies acting on T cell co-stimulation or checkpoint pathways) or require a duration of ≥16 weeks;
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- Adequate organ function.
- Life expectancy is more than 3 months.
- For females of child bearing potential, a negative urine or serum pregnancy test result within 3 days before study treatment.
- Willing and able to provide written informed consent.
Who cannot join
- Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- Previously received immunotherapy and had grade 3 or above immune-related adverse events.
- Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Known active CNS metastases and/or carcinomatous meningitis.
- Received a live vaccine within 4 weeks of the first dose of study medication.
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- Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
- Pregnant or lactating female.
- Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
- Participate in other clinical trials currently or within 4 weeks prior to enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Rui-Hua Xu, MD, PhD
Fenghua Wang, MD, PhD, 86-2087343795, wangfeng@sysucc.org.cn
About this study
Official title: Tucidinostat in Combination With PD-1 Inhibitor and Bevacizumab as Late-line Treatment in Patients With Advanced Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction and Gastric Adenocarcinoma
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.
- Conditions
- Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma
- Being tested
- Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab
- 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.
Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), BevacizumabDrug
Also called Tucidinostat (chidamide) JS001
Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w
approximately 2 years
| Study group | Role | What they receive |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab | Experimental | Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w
approximately 2 years Receives: Drug: Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
Measured: 2 years
Secondary outcomes (4)
Progression-free survival(PFS)
Time from treatment until disease progression or death
Measured: 2 years
Disease Control Rate （DCR）
the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Measured: 2 years
Duration of Response（DoR）
Time from the achievement of a response to progression
Measured: 2 years
Overall survival(OS)
Time from treatment until death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jul 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (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 Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric AdenocarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Ruihua Xu, MD, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163483
- Sponsor's protocol ID
- CSIIT-Q24
- Status last verified
- Jul 2022
- First submitted
- 15 Dec 2021
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tucidinostat in Combination With PD-1 Inhibitor and Bevacizumab as Late-line Treatment in Patients With Advanced Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction and Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05163483
- Acronym / sponsor ID
- CSIIT-Q24
- Conditions
- Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Ruihua XuUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 20 Dec 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 Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab | Experimental | Drug: Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), BevacizumabTucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w approximately 2 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years, ≤ 75 years
- Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.
- Can provide at least 5 pieces of pathological section or fresh tumor tissue
- Eastern Collaborative Oncology Group (ECOG) ≤ 1.
- ≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).
Key exclusion criteria (10 listed)
- Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- Previously received immunotherapy and had grade 3 or above immune-related adverse events.
- Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Known active CNS metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), BevacizumabAlso: Tucidinostat (chidamide) JS001Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w approximately 2 years | Drug | Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab |
Primary outcome
Objective Response Rate（ORR）
Time frame: 2 years
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
4 secondary outcomes
Progression-free survival(PFS)
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Duration of Response（DoR）
Time frame: 2 years
Overall survival(OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Ruihua Xu, MD, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab in people with Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma, run by Ruihua Xu 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 10 inclusion and 10 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 6 Mar 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 fenghua wang, MD, PhD (86-2087343795, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: 2 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 6 Mar 2023.