Immunotherapy Gastroesophageal JunctionPhase 2NCT06396585
The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction
A Phase 2 study testing Tislelizumab, Anlotinib and Oxaliplatin in people with Immunotherapy Gastroesophageal Junction, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunotherapy Gastroesophageal Junction
- What is being tested?
- Tislelizumab, Anlotinib and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Aug 2026
- 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
- Female and male patient ≥ 18 and ≤ 75 years.
- Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient
- ECOG≤1
- No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs).
- Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
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- The expected survival time is more than 6 months.
- Women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study.
- Hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy
- Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
Who cannot join
- Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
- Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required.
- Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- A history of immunodeficiency, including HIV testing positive.
- Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
- Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
- HER2 positive is known.
- Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian cancer hospital
Fuzhou, Fujian, 350500
Ye Zai sheng, doctor, 13950203076, flyingengel@sina.cn
About this study
Official title: The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction : a Prospective，Single-arm, Phase II Trial (TASTE Trial)
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer
- Conditions
- Immunotherapy Gastroesophageal Junction
- Being tested
- Tislelizumab, Anlotinib, Oxaliplatin, Tegafur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W
AnlotinibDrug
Participants will receive anlotinib,12mg, qd，d1-d14，Q3W
OxaliplatinDrug
Participants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W
TegafurDrug
Participants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with anlotinib chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: Anlotinib; Drug: Oxaliplatin; Drug: Tegafur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Secondary outcomes (2)
Major pathological response
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: At the end of Cycle 3 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunotherapy Gastroesophageal JunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396585
- Sponsor's protocol ID
- TASTE Trial
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Tislelizumab Combined With Anlotinib and S1 Plus Oxaliplatin as Neoadjuvant Therapy for the Locally Advanced Adenocarcinoma of Esophagogastric Junction : a Prospective，Single-arm, Phase II Trial (TASTE Trial)
- ClinicalTrials.gov ID
- NCT06396585
- Acronym / sponsor ID
- TASTE Trial
- Conditions
- Immunotherapy Gastroesophageal Junction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 May 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.
To evaluate the efficacy and safety of tislelizumab combined with antilotinib and SOX regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with anlotinib chemotherapy | Experimental | Drug: Tislelizumab, Drug: Anlotinib, Drug: Oxaliplatin, Drug: Tegafur |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female and male patient ≥ 18 and ≤ 75 years.
- Histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (AEG, Siewert II-III)，uT3, uT4a, uT4b any N category, M0, or any T N+ M0 patient
- ECOG≤1
- No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
- Exclusion of distant metastases by CT or MRI of abdomen, pelvis, and thorax, bone scan or MRI (if bone metastases are suspected due to clinical signs).
Key exclusion criteria (8 listed)
- Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
- Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required.
- Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
- A history of immunodeficiency, including HIV testing positive.
- Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
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 |
|---|---|---|
| TislelizumabParticipants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 ,Q3W | Drug | Tislelizumab combined with anlotinib chemotherapy |
| AnlotinibParticipants will receive anlotinib,12mg, qd，d1-d14，Q3W | Drug | Tislelizumab combined with anlotinib chemotherapy |
| OxaliplatinParticipants will receive Oxaliplatin, 130mg/m2, iv, day 1 ,Q3W | Drug | Tislelizumab combined with anlotinib chemotherapy |
| TegafurParticipants will receive S-1 40-60mg/m2/c次，bid ，d1-d14，Q3W | Drug | Tislelizumab combined with anlotinib chemotherapy |
Primary outcome
Pathological complete response
Time frame: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
2 secondary outcomes
Major pathological response
Time frame: 4 weeks after surgery
Objective Response Rate (ORR)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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 Phase 2 study testing Tislelizumab, Anlotinib and Oxaliplatin in people with Immunotherapy Gastroesophageal Junction, 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 10 inclusion and 8 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 7 May 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.
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 Ye Zai sheng, Doctor (13950203076 ext. 86, flyingengel@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 4 weeks after surgery). 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 7 May 2024.