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Trial Title:
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
NCT ID:
NCT06349967
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nab-paclitaxel Combined With Cadonilimab (AK104)
Description:
Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1,
d15, q28d;
Arm group label:
Nab-paclitaxel+Cadonilimab (AK104)
Summary:
Currently, standard treatment options for gastric cancer failed to first-line treatment
include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or
paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still
far from satisfactory. The aim of the study is to evaluate the efficacy and safety of
nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced
gastric cancer.
Detailed description:
This trial is a prospective, multicenter, single arm, phase II clinical study. It is
divided into three stages: screening period, treatment period, and follow-up period. The
main research objective of this study is to evaluate the objective response rate (ORR) of
albumin paclitaxel combined with kandelizumab (AK104) in second-line treatment of gastric
cancer with failed first-line fluorouracil/platinum combination immunotherapy. Secondary
study objective: To evaluate the disease control rate (DCR), progression free survival
(PFS), overall survival (OS), safety, tolerability, and impact on patient quality of life
(QoL) of albumin paclitaxel combined with candelizumab (AK104) in second-line treatment
of gastric cancer with failed first-line fluorouracil/platinum immunotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years.
2. Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with
peritoneal metastasis through laparoscopic exploration and pathological/cytological
examination.
3. No previous antitumor treatment.
4. Agree to provide blood/tissue specimens.
5. The expected survival is longer than 3 months.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status≤1.
7. Adequate organ function including the following:
1. Total bilirubin ≤1.5 times the upper limit of normal (ULN);
2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
3. Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
4. Serum creatinine≤1.5×ULN;
5. Serum amylase and lipase≤1.5×ULN;
6. International standardized ratio (INR)/partial thromboplastin time
(PTT)≤1.5×ULN;
7. Platelet count ≥ 75,000 /mm3;
8. Hemoglobin (Hb) ≥ 9 g/dL;
9. Absolute neutrophil count (ANC) ≥ 1500/mm3;
8. Strict contraception.
9. 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.
Exclusion Criteria:
1. Undergoing other clinical trials or having participated in any drug clinical trials
one month before enrollment.
2. Hyperprogression occurs in first-line immunotherapy: (1) Tumor burden increased more
than 50% compared to baseline upon the first assessment (2-4 cycles of first-line
treatment); (2) Tumor growth rate exceeded the previous rate by more than twice
after immunotherapy.
3. Active autoimmune disease or history of refractory autoimmune disease.
4. Grade 3-4 immune hepatitis, immune pneumonia, immune myocarditis, etc. appear in
first-line immunotherapy.
5. 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.
6. HER2 positive patients who did not receive trastuzumab in first-line treatment.
7. Active or clinically significant cardiac disease:
1. Congestive heart failure > New York Heart Association (NYHA) class 2;
2. Active coronary artery disease;
3. Arrhythmias requiring treatment other than β-blockers or digoxin;
4. Unstable angina (with angina symptoms at rest), new angina within 3 months
before enrollment, or new myocardial infarction within 6 months before
enrollment.
8. Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6
months prior to enrollment.
9. 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.
10. Patients with a history of HIV infection or active hepatitis B/C.
11. Ongoing > level 2 infection.
12. Symptomatic brain metastasis or meningioma.
13. Unhealed wounds, ulcers or fractures.
14. Renal failure patients requiring blood or peritoneal dialysis.
15. Epileptic that needs medication.
16. Active, symptomatic interstitial lung disease, pleural effusion or ascites that
causes breathing difficulties (≥ grade 2 breathing difficulties).
17. History of organ transplantation (including corneal transplantation).
18. Allergy to research drugs or similar drugs, or suspected allergies.
19. Pregnant or lactating women.
20. Medical, psychological or social conditions can affect the recruitment of patients
and evaluation of study results.
21. Other antitumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy,
biotherapy, chemoembolization) other than investigator drugs. Palliative external
irradiation for non-target lesions is allowed.
22. Previously used similar chemotherapy drugs or immune checkpoint inhibitors;
23. Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery.
24. Treatment with antitumor Chinese herbal medicine.
25. Vaccination history 4 weeks prior to enrollment
26. The investigator believes that patients who are not suitable for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 30, 2024
Completion date:
May 30, 2027
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06349967
