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Recruiting
NCT07920224
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Conditions: Stomach Neoplasms
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 59
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Location: Union Hospital Wuhan Hubei
Summary
This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
1. Have a full understanding of the study and voluntarily sign the informed consent form;
2. Aged 18 to 75 years (inclusive);
3. Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma;
4. Prior failure of first-line standard chemotherapy;
5. HER2-negative status;
6. ECOG performance status of 0 to 2;
7. Expected survival of ≥3 months;
8. Presence of at least one measurable lesion, defined as:
* Longest diameter ≥10 mm as assessed by spiral CT scan;
* Diameter ≥20 mm as assessed by conventional CT scan(per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1);
9. Major organ function meeting the following requirements (use of any blood products or hematopoietic growth factors within 14 days prior to enrollment is not permitted):
* Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
* Platelet (PLT) count ≥100 × 10⁹/L;
* Hemoglobin (Hb) ≥90 g/L;
* Total bilirubin (TBIL) \ 1 × 10⁴ copies/mL or \> 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (\> 1 × 10³ copies/mL)\];
19. Unresolved toxicities above CTCAE v5.0 Grade 1 resulting from any prior anticancer treatment, excluding alopecia, lymphopenia, and ≤ Grade 2 neurotoxicity caused by oxaliplatin;
20. Pregnant females (positive pregnancy test prior to drug administration) or females who are breastfeeding;
21. Receipt of blood transfusion, blood products, or hematopoietic factors (e.g., albumin, granulocyte colony-stimulating factor \[G-CSF\]) within 14 days prior to enrollment;
22. Any other diseases, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities; conditions judged by the investigator to make the subject unsuitable for study drug administration (e.g., epilepsy requiring treatment), potentially interfere with the interpretation of study results, or place the subject at high risk;
23. Urinalysis indicating urinary protein ≥ 2+ and 24-hour urinary protein excretion \> 1.0 g;
24. Complications requiring long-term immunosuppressive therapy, or systemic or local use of immunosuppressive corticosteroids (\> 10 mg/day prednisone or equivalent therapeutic hormones);
25. Subjects deemed unsuitable for enrollment in this study by the investigator.
Source: ClinicalTrials.gov (NCT07920224). StuddyBuddy aggregates publicly available trial information.