Gastric Cancer
Conditions
Keywords
Second-line treatment population,Patients who have received immunotherapy
Brief summary
Phase II Clinical Study of Adebrelimab Combined with Apatinib and Paclitaxel for Injection(Albumin Bound) as Second-line Therapy in Patients with Advanced Gastric Cancer Previously Treated with Immunotherapy
Detailed description
To observe and evaluate the efficacy of Adebrelimab combined with Apatinib and Paclitaxel for Injection(Albumin Bound) in second-line treatment of advanced gastric cancer.
Interventions
DRUGAdebrelimab+Apatinib+Paclitaxel for Injection(Albumin Bound)
Adebrelimab injection：Intravenous infusion, fixed dose 1200 mg, Day 1, Q3W. Until disease progression or intolerable toxicity occurs, the infusion should be administered over 30 to 60 minutes and over a maximum of 2 hours. When adalimumab is administered in combination with chemotherapy, Adebrelimab should be administered as an intravenous infusion first, followed by chemotherapy at least 30 minutes apart. Apatinib mesylate：Administered orally, 250 mg/time, once daily, orally, half an hour after meals (the time of daily administration should be as same as possible), with warm boiled water, the missed dose of Apatinib during the course of treatment cannot be supplemented. Paclitaxel for Injection(Albumin Bound)：Intravenous infusion, 250 mg/m2, day 1, Q3W, intravenous drip over 30 minutes.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age: 18 years and older, male or female. 2. patients with pathologically or cytologically confirmed gastric cancer (GC) or gastroesophageal junction cancer (GEJ). 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 4. measurable lesions that meet RECIST1.1 criteria. 5. Patients with gastric cancer who have progressed on first-line immunotherapy have achieved CR or PR or SD ≥ 3 months on the first immunotherapy; 6. expected survival ≥ 3 months; 7. Normal function of major organs, no severe blood, heart, lung, liver and kidney dysfunction and immunodeficiency diseases. Laboratory tests were to meet the following requirements: neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109/L) (no growth factors used within 14 days); platelet count (PLT) ≥ 100,000/mm3 (100 × 109/L) (no corrective treatment used within 7 days); hemoglobin (Hb) ≥ 9 g/dL (90 g/L) (no corrective treatment used within 7 days); serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) levels ≤ 2.5 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastases. Serum Cr ≤ 1.5 times ULN, endogenous creatinine clearance \> 50ml/min (Cockcroft-Gault formula); Normal urine routine, or urine protein \< (+ +), or 24-hour urine protein \< 1.0g; 8. normal coagulation function, no active bleeding and thrombosis disease: international normalized ratio INR ≤ 1.5 × ULN; partial thromboplastin time APTT ≤ 1.5 × ULN; prothrombin time PT ≤ 1.5ULN; 9. Patients with potential fertility need to use a medically recognized contraceptive (such as intrauterine device, contraceptives or condoms) during study treatment and within 3 months after the end of study treatment; and must have a negative serum HCG test within 72 hours before study enrollment; and must be non-lactating. I agree and have signed an informed consent form and am willing and able to comply with scheduled visits, study treatment plan, laboratory tests, and other trial procedures.
Exclusion criteria
1. history of gastrointestinal perforation and/or fistula within 6 months before the first dose; 2. presence of uncontrollable pleural effusion, pericardial effusion, or abdominal effusion requiring repeated drainage; 3. previous history of hypersensitivity to monoclonal antibodies, any component of adalimumab, and nab-paclitaxel; 4. received any of the following treatments: a. previously received immunotherapy with serious adverse reactions; b. received any investigational drug within 4 weeks before the first use of study drug; c. enrolled in another clinical study at the same time, unless it was an observational (non-interventional) clinical study or interventional clinical study follow-up; d. received the last dose of anticancer therapy ≤ 3 weeks before the first use of study drug and received fixed-field palliative radiotherapy ≤ 2 weeks before the first study intervention treatment; e. subjects who required corticosteroids (\> 10 mg prednisone equivalent dose per day) within 2 weeks before the first use of study drug. Other special situations require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \> 10 mg/day prednisone efficacy dose are allowed; f. those who have received anti-tumor vaccines or live vaccines within 4 weeks before the first dose of study drug; g. major surgery or severe trauma within 4 weeks before the first dose of study drug; 5. previous anti-tumor treatment toxicity did not recover to ≤ CTCAE grade 1 (except alopecia) or the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 3 years | The proportion of patients with a confirmed complete response or partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 3 years | The time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first |
| DCR | up to 3 years | The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease |
| OS | up to 3 years | The time from randomization to death from any reason |
Contacts
Primary ContactGuanghai Dai, Doctor
Outcome results
None listed