Gastric CancerPhase 1/2NCT06266871
SOX Combined With Tislelizumab and LDRT for Neoadjuvant Treatment of Locally Advanced Gastric Cancer
A Phase 1/2 study testing SOX+Tislelizumab+LDRT in people with Gastric Cancer, run by West China Hospital.
Trial summary
Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- SOX+Tislelizumab+LDRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2024to 30 Jul 2026
- Phase
- Phase 1/2
- 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 18-75 years.
- Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT3-T4a, N+, M0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
- Resectable G/GEJ cancer, as judged by experienced surgeons.
- Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1.
- Agree to provide blood, feces, and tissue specimens.
- The expected survival is longer than 3 months.
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- There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects).
- Adequate organ and hematological function.
- Strict contraception.
- Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Who cannot join
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
- Allergic to oxaliplatin, S-1, tislelizumab and similar drugs, or suspected allergies.
- With serious gastrointestinal diseases that affect the absorption of oral chemotherapy drugs, such as chronic inflammatory bowel disease.
- History of gastric perforation within 6 months.
- Clinical manifestations include significant arrhythmia, myocardial ischemia, severe atrioventricular block, heart failure, and severe heart valve disease; Or those with severe lung function impairment; Or those with impaired blood system, liver and kidney function who cannot tolerate radiotherapy and chemotherapy; Or severe bone marrow failure; Or those with uncontrollable infections.
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- With uncontrollable mental illness.
- Pregnant or lactating women.
- Unable to comply with the research program or procedures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SOX Combined With Tislelizumab and Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial
Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.
Read the detailed description
This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 5 cases will be enrolled in each treatment group. In the phase II study, a total of 44 patients will be enrolled. Eligible patients will be registered and receive three cycles of SOX plus tislelizumab regimen. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of chemotherapy plus tislelizumab. The primary endpoint of Phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 2-year disease-free survival (DFS) rate, 2-year overall survival (OS) rate and safety profile of the neoadjuvant regimen.
- Conditions
- Gastric Cancer
- Being tested
- SOX+Tislelizumab+LDRT
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOX+Tislelizumab+LDRTDrug
All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w.
LDRT will be performed in the target area. After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab.
Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab.
The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles.
| Study group | Role | What they receive |
|---|---|---|
| SOX+Tislelizumab+LDRT | Experimental | Laparoscopic exploration is required in all patients to detect occult peritoneal metastases.
All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w.
Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes).
After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab regimen.
Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab regimen.
The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles. Receives: Drug: SOX+Tislelizumab+LDRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy
Measured: 5 months after the last subject participating in
Secondary outcomes (5)
R0 resection rate
defined as the rate of the complete surgical removal of any residual cancer cells in the tumor bed
Measured: 5 months after the last subject participating in
MPR rate
defined as tumor residual cells ≤10% in the surgical specimen
Measured: 5 months after the last subject participating in
ORR
defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR)) before surgery
Measured: 5 months after the last subject participating in
2-year disease-free survival (DFS) rate
defined as the proportion of patients without disease relapse 2 years after enrolment
Measured: every 3 month postoperation up to 24 months
2-year OS rate
defined as the proportion of patients survived 2 years after enrolment
Measured: every 3 month postoperation up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start10 Mar 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by West China 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Liu, West China Hospital
- Investigators
- Mojin Wang, M.D., Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266871
- Sponsor's protocol ID
- WCH-2023-1625
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang PF, Chen Y, Li WK, Luo ZM, Chen J, Qian K, Chen XD, Wang MJ, Liu M. SOX combined with tislelizumab and low-dose radiation therapy for the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase Ib/II clinical trial. Front Immunol. 2024 Nov 13;15:1431957. doi: 10.3389/fimmu.2024.1431957. eCollection 2024.
PubMed 39606219
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOX Combined With Tislelizumab and Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial
- ClinicalTrials.gov ID
- NCT06266871
- Acronym / sponsor ID
- WCH-2023-1625
- Conditions
- Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 20 Feb 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.
Neoadjuvant chemotherapy or chemoradiotherapy has become the standard neoadjuvant regimen for locally advanced G/GEJ cancer and has been recommended by a series of treatment guidelines. Although with clinical benefits of neoadjuvant chemotherapy or chemoradiotherapy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with tislelizumab and LDRT in the neoadjuvant treatment for locally advanced G/GEJ cancer.
Detailed description
This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 5 cases will be enrolled in each treatment group. In the phase II study, a total of 44 patients will be enrolled. Eligible patients will be registered and receive three cycles of SOX plus tislelizumab regimen. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of chemotherapy plus tislelizumab. The primary endpoint of Phase Ib is to determine the optimal radiation dose for phase II study. The primary endpoint of phase II is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), objective response rate (ORR), 2-year disease-free survival (DFS) rate, 2-year overall survival (OS) rate and safety profile of the neoadjuvant regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOX+Tislelizumab+LDRT | Experimental | Drug: SOX+Tislelizumab+LDRTLaparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. Then, LDRT will be performed in the target area (including the primary gastric lesion and positive/suspected positive lymph nodes). After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab regimen. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab regimen. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles. |
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 18-75 years.
- Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT3-T4a, N+, M0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
- Resectable G/GEJ cancer, as judged by experienced surgeons.
- Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1.
- Agree to provide blood, feces, and tissue specimens.
Key exclusion criteria (9 listed)
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
- Allergic to oxaliplatin, S-1, tislelizumab and similar drugs, or suspected allergies.
- With serious gastrointestinal diseases that affect the absorption of oral chemotherapy drugs, such as chronic inflammatory bowel disease.
- History of gastric perforation within 6 months.
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 |
|---|---|---|
| SOX+Tislelizumab+LDRTAll patients will start with one cycle of neoadjuvant therapy of SOX plus tislelizumab regimen: S-1: 40-60 mg Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; tislelizumab: 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another two cycles of SOX plus tislelizumab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of SOX plus tislelizumab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with SOX regimen for up to 5 cycles. | Drug | SOX+Tislelizumab+LDRT |
Primary outcome
pCR rate
Time frame: 5 months after the last subject participating in
defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy
5 secondary outcomes
R0 resection rate
Time frame: 5 months after the last subject participating in
MPR rate
Time frame: 5 months after the last subject participating in
ORR
Time frame: 5 months after the last subject participating in
2-year disease-free survival (DFS) rate
Time frame: every 3 month postoperation up to 24 months
2-year OS rate
Time frame: every 3 month postoperation up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39606219Zhang PF, Chen Y, Li WK, Luo ZM, Chen J, Qian K, Chen XD, Wang MJ, Liu M. SOX combined with tislelizumab and low-dose radiation therapy for the neoadjuvant treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase Ib/II clinical trial. Front Immunol. 2024 Nov 13;15:1431957. doi: 10.3389/fimmu.2024.1431957. eCollection 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.
Mojin Wang, M.D. study director
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SOX+Tislelizumab+LDRT in people with Gastric Cancer, run by West China Hospital.
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 9 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ming Liu, M.D (+8618980606324, mingliu721@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 5 months after the last subject participating in). 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 NCT06266871, which also lists 1 linked publication.
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 Feb 2024.