- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06349967
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
March 31, 2024 updated by: Ming Liu, West China Hospital
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer: A Prospective, Multicenter, Single-arm, Phase II Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
59
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: Pengfei Zhang, M.D
- Phone Number: +86-17828163584
- Email: fly_121988@126.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:
- Age 18-75 years.
- Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological/cytological examination.
- No previous antitumor treatment.
- Agree to provide blood/tissue specimens.
- The expected survival is longer than 3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status≤1.
Adequate organ function including the following:
- Total bilirubin ≤1.5 times the upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
- Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
- Serum creatinine≤1.5×ULN;
- Serum amylase and lipase≤1.5×ULN;
- International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
- Platelet count ≥ 75,000 /mm3;
- Hemoglobin (Hb) ≥ 9 g/dL;
- Absolute neutrophil count (ANC) ≥ 1500/mm3;
- Strict contraception.
- 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:
- Undergoing other clinical trials or having participated in any drug clinical trials one month before enrollment.
- 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.
- Active autoimmune disease or history of refractory autoimmune disease.
- Grade 3-4 immune hepatitis, immune pneumonia, immune myocarditis, etc. appear in first-line immunotherapy.
- 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.
- HER2 positive patients who did not receive trastuzumab in first-line treatment.
Active or clinically significant cardiac disease:
- Congestive heart failure > New York Heart Association (NYHA) class 2;
- 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.
- Gastrointestinal perforation, obstruction, or uncontrollable diarrhea in the 6 months prior to 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 lung disease, pleural effusion or ascites that causes breathing difficulties (≥ grade 2 breathing difficulties).
- History of organ transplantation (including corneal transplantation).
- Allergy to research drugs or similar drugs, or suspected allergies.
- Pregnant or lactating women.
- 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 chemotherapy drugs or immune checkpoint inhibitors;
- Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery.
- Treatment with antitumor Chinese herbal medicine.
- Vaccination history 4 weeks prior to enrollment
- The investigator believes that patients who are not suitable for the study.
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: Nab-paclitaxel+Cadonilimab (AK104)
Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;
|
Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate (ORR)
Time Frame: every 3 month postoperation up to 24 months
|
the proportion of patients with the best overall response of complete response (CR) or partial response (PR)
|
every 3 month postoperation up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease control rate (DCR)
Time Frame: every 3 month postoperation up to 24 months
|
the proportion of patients with the best overall response of CR or PR or stable disease (SD)
|
every 3 month postoperation up to 24 months
|
overall survival (OS)
Time Frame: every 3 month postoperation up to 24 months
|
defined as the time from randomization to death
|
every 3 month postoperation up to 24 months
|
progression-free survival (PFS)
Time Frame: every 3 month postoperation up to 24 months
|
defined as the time from randomization to disease progression
|
every 3 month postoperation up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ming Liu, M.D., West China Hospital
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 (Estimated)
April 30, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
May 30, 2027
Study Registration Dates
First Submitted
March 31, 2024
First Submitted That Met QC Criteria
March 31, 2024
First Posted (Actual)
April 5, 2024
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
March 31, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- WCH-2023-1592
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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