Compares HLX18 with OPDIVO in adults after surgery for solid tumors
Compares HLX18 with OPDIVO in adults after surgery for esophageal cancer, melanoma or bladder cancer.
Plain-language title generated from the registry record
Registry title: A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Key facts
- Where
- Fuzhou, Hangzhou, Luoyang, Tianjin, Wenzhou, Wuhan, and Xi'an, ChinaSee the 7 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07518043, who can take part
Where in China
- Fujian Medical University Union HospitalFuzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The First Affiliated Hospital of Henan University of Science &TechnologyLuoyang, ChinaTaking people
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Henlius Biotech
- Trial code
- NCT07518043
- Record updated
- 27 July 2026
- Original description
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
Inclusion: Participants must have signed and dated an IRB/IEC approved written informed consent form; Aged 18 to 70 years at the time of signing the ICF; 18 kg/m² ≤ BMI ≤ 30 kg/m² and 50 kg ≤ body weight ≤ 85 kg; Histologically confirmed solid tumors (EC/GEJC, Melanoma, or UC) status post R0 resection; For EC/GEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection; For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins; For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0); Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization; Adequate recovery from prior surgery or systemic therapy; ECOG Performance Status of 0; Adequate organ function; Agreement to use effective contraception (negative pregnancy test for WOCBP).
Exclusion: History of illicit drug use or alcohol abuse within 12 months prior to randomization; UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy; EC/GEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible); Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4); Use of systemic corticosteroids (>10 mg/day prednisone equivalent), immunosuppressants, or live vaccines within 28 days; Recent or planned participation in other investigational drug, device, or surgical studies; Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma; Other primary active malignancies within 5 years or history of organ/bone marrow transplantation; Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities; Active autoimmune disease requiring systemic immunosuppressive therapy; Known HIV infection, active Hepatitis B/C, or active pulmonary tuberculosis; Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis; Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator; Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc > 450ms/470ms) within 6 months; Chronic heart failure (NYHA Class III-IV) or LVEF < 50% at screening; The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.