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New treatment option for Esophageal and/or Cardia Cancer
Official title A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
ClinicalTrials.gov ID: NCT07518043
What this study is testing
What is HLX18?
HLX18 is an investigational medicine, being studied as a potential treatment for esophageal and/or cardia cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- History of illicit drug use or alcohol abuse within 12 months prior to randomization.
- Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
- 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).
- Other primary active malignancies within 5 years or history of organ/bone marrow transplantation.
See the full eligibility criteria
- 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).
- History of illicit drug use or alcohol abuse within 12 months prior to randomization.
- Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC/GEJC, or ocular melanoma.
- 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).
- Other primary active malignancies within 5 years or history of organ/bone marrow transplantation.
- 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.
- 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.
- 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.
- Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.
- The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, China
- Hangzhou, China
- Luoyang, China
- Tianjin, China
- Wenzhou, China
- Wuhan, China
- Xi'an, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, China; Hangzhou, China; Luoyang, China; Tianjin, China; Wenzhou, China; Wuhan, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.