Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer

NCT06349967 | Not Yet Recruiting Phase 2

• 1 other identifier: WCH-2023-1592
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• overall response rate (ORR)

  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 Outcomes (3)

• disease control rate (DCR)

  every 3 month postoperation up to 24 months

• overall survival (OS)

  every 3 month postoperation up to 24 months

• progression-free survival (PFS)

  every 3 month postoperation up to 24 months

Study Arms (1)

Nab-paclitaxel+Cadonilimab (AK104)

EXPERIMENTAL

Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;

Drug: Nab-paclitaxel Combined With Cadonilimab (AK104)

Interventions

Nab-paclitaxel Combined With Cadonilimab (AK104) DRUG

Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;

Nab-paclitaxel+Cadonilimab (AK104)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• Wei J, Zhang P, Hu Q, Cheng X, Shen C, Chen Z, Zhuang W, Yin Y, Zhang B, Gou H, Yang K, Bi F, Liu M. Nab-paclitaxel combined with cadonilimab (AK104) as second-line treatment for advanced gastric cancer: protocol for a phase II prospective, multicenter, single-arm clinical trial. Front Immunol. 2025 Feb 25;16:1519545. doi: 10.3389/fimmu.2025.1519545. eCollection 2025.

  PMID: 40070819 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Ming Liu, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Zhang, M.D

CONTACT

+86-17828163584; fly_121988@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share