To hear about similar clinical trials, please enter your email below
Trial Title:
Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC
NCT ID:
NCT06371586
Condition:
Gastric Cancer
Diffuse Type Carcinoma
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
Description:
Albumin paclitaxel+SOX+BEV bi weekly neoadjuvant therapy for 6 cycles, with PD-1
monoclonal antibody therapy interspersed for 4 cycles. Review CT and gastroscopy every 3
cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective
after 6 cycles of treatment may consider surgery; Or continue the two-week regimen of
albumin paclitaxel+bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles.
Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or
maintenance medication treatment will be determined based on the therapeutic effect.
Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative
and pathological results of the surgery. Those who fail to evaluate during neoadjuvant
therapy will undergo surgery or radiation therapy, or switch to a second-line systemic
treatment plan.
Arm group label:
Experimental arm
Other name:
PSBP
Summary:
The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during
which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced
diffuse gastric cancer.
Detailed description:
The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6
cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles.
Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who
have been evaluated as effective after 6 cycles of treatment may consider surgery; Or
continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1
monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated,
and surgery, radiotherapy, or maintenance medication treatment will be determined based
on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after
surgery based on the curative and pathological results of the surgery. Those who fail to
evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch
to a second-line systemic treatment plan.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Local advanced diffuse or mixed type gastric cancer detected by pathology and
endoscopy;
2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound,
gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric
cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
3. Has not received any anti-tumor treatment for gastric cancer yet;
4. Age range from 18 to 75 years old;
5. ECOG score 0-1 points;
6. Liver and kidney function and blood routine meet the following conditions:
Neutrophils>1.5G/L, Hb>90g/L, PLT>100G/L; ALT and AST<2.5ULN; TBIL<1.5 ULN;
Cr<1.0ULN;
7. Left ventricular ejection fraction>60%;
8. Good compliance and ability to accept long-term follow-up;
9. Sign informed consent.
Exclusion Criteria:
1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
2. Those who cannot swallow pills;
3. Diagnose immunodeficiency or active autoimmune diseases, have received or are
currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive
drugs within the past two years;
4. Interstitial pneumonia;
5. Moderate to severe cirrhosis caused by any reason;
6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular
and cerebrovascular diseases;
7. Active infections that require systemic treatment;
8. Previously suffered from other tumors, excluding cured skin cancer and cervical
cancer in situ;
9. Internal medicine diseases that do not meet the chemotherapy criteria at the same
time;
10. Pregnant and lactating patients;
11. Individuals with a history of mental illness and poor compliance.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital，Chinese acadamy of medical sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunxia Du
Phone:
87787121
Email:
retinadcx@vip.163.com
Start date:
March 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06371586
