- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383559
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
April 24, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients, a Multi-center, Prospective, Single-arm Phase II Trial
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer.
This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital.
Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy.
In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled.
Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death.
The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (>=60kg, 200 mg; <60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day).
Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.
Safety will be evaluated by AE and laboratory tests.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ting Deng, MD
- Phone Number: 1053 022-23340123
- Email: xymcdengting@126.com
Study Contact Backup
- Name: Yi Ba, MD
- Phone Number: 1053 022-23340123
- Email: bayi@tjmuch.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- Ting Deng, MD
- Phone Number: 1053 022-23340123
- Email: xymcdengting@126.com
-
Contact:
- Yi Ba, MD
- Phone Number: 1053 022-23340123
- Email: bayi@tjmuch.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients ≥18 years old;
- Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, AFP ≥ 20ng / ml;
- No previous palliative systemic treatment;
- There are measurable metastatic lesions according to RECIST version 1.1;
- ECOG physical status score is 0 or 1;
- Normal organ function: Neutrophil count ≥ 1.2 × 109/L, Platelet count ≥ 100 × 109/L, Hemoglobin (HB) ≥ 80g/L, Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L, Creatinine ≤ 1.5 times* upper limit of normal, International standardization ratio (INR) ≤ 1.5;
- Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein/creatinine (UPC) ratio < 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg;
- Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0);
- For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment;
- Patients who can take oral drugs;
- Signed the informed consent.
Exclusion Criteria:
- 1. Patients who received surgery and radiotherapy within 2 weeks before enrollment; 2. Patients who have previously been treated with Lenvatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; 3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg); 4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment; 5. Patients with symptomatic brain metastases; 6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months; 7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) 8. The patients have severe (hospitalized) complications 9. Patients with a history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment; 10. Patients with active hepatitis; 11. Patients with a history of human immunodeficiency virus (HIV) infection; 12. Patients with symptoms or signs of active interstitial pulmonary disease; 13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases; 14. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine < 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental arm
XELOX regimen combined with Sintilimab and Lenvatinib
|
XELOX regimen combined with Sintilimab and Lenvatinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 24 months
|
the rate of patients with PR and CR
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 24 months
|
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
|
24 months
|
OS
Time Frame: 24 months
|
The time from the beginning of treatment to the time when the patient dies from any cause
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AE
Time Frame: 24 months
|
Safety will be evaluated by AE
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJMUCH-GI-GC07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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