Gastric CancerPhase 1/2NCT06426654
Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer
A Phase 1/2 study testing sintiliman plus LDRT in people with Gastric Cancer, run by West China Hospital.
Trial summary
Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- sintiliman plus LDRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 30 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT2N+M0 or cT3-4aNanyM0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
- Resectable G/GEJ cancer, as judged by experienced surgeons.
- dMMR and/or MSI-H.
- 4. Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1. 5. Agree to provide blood, feces, and tissue specimens. 6. The expected survival is longer than 6 months. 7. There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects).
- 8. Adequate organ and hematological function. 9. Strict contraception. 10. 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
- Unable to comply with the research program or procedures.
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroids (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA) class 2;
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- Active coronary artery disease;
- Arrhythmias requiring treatment other than β-blockers or digoxin;
- Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months 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.
- Patients with a history of HIV infection or active hepatitis B/C.
- Ongoing > level 2 infection.
- Symptomatic brain metastasis or meningioma.
- Unhealed wounds, ulcers or fractures.
- Renal failure patients requiring blood or peritoneal dialysis.
- Epileptic that needs medication.
- Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade).
- History of organ transplantation (including corneal transplantation).
- Allergic to research drugs or similar drugs, or suspected allergies.
- Pregnant or lactating women.
- The investigator believes that patients who are not suitable for the study.
- Medical, psychological or social conditions can affect the recruitment of patients and evaluation of study results.
- Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs. Palliative external irradiation for non-target lesions is allowed.
- Previously used similar immune checkpoint inhibitors.
- Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery (excluding biliary stents, or percutaneous biliary drainage).
- Treatment with antitumor Chinese herbal medicine.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch Repair/Microsatellite Instability-high Gastric Cancer: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial
Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer.
Read the detailed description
This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 4 cases will be enrolled in each treatment group. In the phase II study, a total of 33 patients will be enrolled. Eligible patients will be registered and receive four cycles of sintilimab. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. 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), 3-year event-free survival (EFS) rate, 3-year overall survival (OS) rate and safety profile of the neoadjuvant regimen.
- Conditions
- Gastric Cancer
- Being tested
- sintiliman plus LDRT
- Keywords
- gastric cancer, neoadjuvant therapy, sintilimab, 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.
sintiliman plus LDRTDrug
All patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w.
LDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab.
Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab.
The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles.
| Study group | Role | What they receive |
|---|---|---|
| sintilimab+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 sintilimab: 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 three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab.
The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. Receives: Drug: sintiliman plus 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 (4)
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
3-year event-free survival (DFS)
defined as the proportion of patients without event 23 years after enrolment
Measured: every 3 month postoperation up to 36 months
2-year OS rate
defined as the proportion of patients survived 3 years after enrolment
Measured: every 3 month postoperation up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start10 Jun 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 45 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
- Kun Yang, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426654
- Sponsor's protocol ID
- WCH242145
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 23 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Low-dose Radiation Therapy for Neoadjuvant Treatment of Locally Advanced Deficient Mismatch Repair/Microsatellite Instability-high Gastric Cancer: a Prospective, Multi-center, Single-arm, Phase Ib/II Clinical Trial
- ClinicalTrials.gov ID
- NCT06426654
- Acronym / sponsor ID
- WCH242145
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, neoadjuvant therapy, sintilimab, LDRT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 23 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.
Recently, growing evidences have suggested that immunotherapy represents a promising treatment option for the neoadjuvant treatment of locally advanced mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) gastric cancer. In this study, we will explore the efficacy and safety of sintilimab and LDRT in the neoadjuvant treatment for locally advanced dMMR/MSI-H G/GEJ cancer.
Detailed description
This is a prospective, multicenter, single-arm, phase Ib/II trial. In the phase Ib, 4 cases will be enrolled in each treatment group. In the phase II study, a total of 33 patients will be enrolled. Eligible patients will be registered and receive four cycles of sintilimab. Simultaneously, LDRT will be planned and administered. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. 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), 3-year event-free survival (EFS) rate, 3-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 |
|---|---|---|
| sintilimab+LDRT | Experimental | Drug: sintiliman plus LDRTLaparoscopic exploration is required in all patients to detect occult peritoneal metastases. All patients will start with one cycle of neoadjuvant therapy of sintilimab: 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 three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years.
- Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT2N+M0 or cT3-4aNanyM0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
- Resectable G/GEJ cancer, as judged by experienced surgeons.
- dMMR and/or MSI-H.
- 4. Eastern Cooperative Oncology Group performance score (ECOG PS) ≤1. 5. Agree to provide blood, feces, and tissue specimens. 6. The expected survival is longer than 6 months. 7. There was no previous antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, interventional therapy, and other treatments with antitumor effects).
Key exclusion criteria (26 listed)
- Unable to comply with the research program or procedures.
- Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- Active autoimmune disease or history of refractory autoimmune disease.
- Receiving corticosteroids (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- Active or clinically significant cardiac disease:
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 |
|---|---|---|
| sintiliman plus LDRTAll patients will start with one cycle of neoadjuvant therapy of sintilimab: sintilimab 200 mg, iv drip, d1, q3w. LDRT will be performed in the target area. After radiotherapy, patients will receive another three cycles of sintilimab. Radical D2 gastric cancer resection will be performed 4-6 weeks after the last administration of sintilimab. The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with sintilimab for up to 10 cycles. | Drug | sintilimab+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
4 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
3-year event-free survival (DFS)
Time frame: every 3 month postoperation up to 36 months
2-year OS rate
Time frame: every 3 month postoperation up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
Kun Yang, M.D. principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sintiliman plus 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 6 inclusion and 26 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: opening soon, as of the sponsor's last update on 23 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Zhang, M.D (+86-17828163584, fly_121988@126.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?
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 23 May 2024.