Esophageal and/or Cardia CancerPhase 1NCT07518043
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
A Phase 1 study testing HLX18 and OPDIVO® in people with Esophageal and/or Cardia Cancer and Melanoma, run by Shanghai Henlius Biotech at 7 sites in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)
- What is being tested?
- HLX18 and OPDIVO®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 7 sitesChina
- Study dates
- 15 Jul 2026to 13 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou
Jinhuo Lai, 571747377@qq.com
- Recruiting
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou
Jian Ruan, software233@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang
Shegan Gao, gaoshegangcp@126.com
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin
Hailong Hu, huhailong_yd2y@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Hongde Chen, 85404206@qq.com
- Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan
Jing Chen, bswhunion@163.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Yinbin Zhang, 23227119@qq.com
About this study
Official title: 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).
- Being tested
- HLX18, OPDIVO®
- Medical subject headings
- Melanoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX18Drug
Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle
OPDIVO®Drug
Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle
| Study group | Role | What they receive |
|---|---|---|
| HLX18 | Experimental | Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle, until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). Receives: Drug: HLX18 |
| OPDIVO® | Active comparator | Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle, for a total of 4 cycles (16 weeks). After 4 cycles, all participants in the OPDIVO® group will receive HLX18 480 mg on Day 1 of each 4-week cycle until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). Receives: Drug: OPDIVO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-28d
Measured: From time 0 to 28 days after the 1st dose(4 weeks)
AUCss
Measured: From time 0 to 28 days after the 4th dose(16 weeks)
Secondary outcomes (8)
maximum serum drug concentration (Cmax)
Measured: up to 16 weeks
trough serum drug concentration (Ctrough)
Measured: up to 16 weeks
maximum serum drug concentration at steady state (Cmax,ss)
Measured: up to 16 weeks
trough serum drug concentration at steady state (Ctrough,ss)
Measured: up to 16 weeks
Disease-free survival (DFS)
Measured: up to 12 months
Adverse events (AEs); Serious adverse events (SAEs); Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions)
Measured: From enrollment to the end of 90-day safety follow-up (up to 15 months)
Number of participants with abnormal vital signs, abnormal physical examination findings, abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers) or abnormal 12-lead ECG readings.
Measured: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start15 Jul 2026
- Primary completion12 Aug 2027 (estimated)
- Study completion13 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and/or Cardia CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518043
- Sponsor's protocol ID
- HLX18-MRST001
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07518043
- Acronym / sponsor ID
- HLX18-MRST001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 13 Jun 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HLX18 | Experimental | Drug: HLX18Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle, until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). |
| OPDIVO® | Active comparator | Drug: OPDIVO®Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle, for a total of 4 cycles (16 weeks). After 4 cycles, all participants in the OPDIVO® group will receive HLX18 480 mg on Day 1 of each 4-week cycle until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX18Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle | Drug | HLX18 |
| OPDIVO®Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle | Drug | OPDIVO® |
Primary outcome
AUC0-28d
Time frame: From time 0 to 28 days after the 1st dose(4 weeks)
AUCss
Time frame: From time 0 to 28 days after the 4th dose(16 weeks)
8 secondary outcomes
maximum serum drug concentration (Cmax)
Time frame: up to 16 weeks
trough serum drug concentration (Ctrough)
Time frame: up to 16 weeks
maximum serum drug concentration at steady state (Cmax,ss)
Time frame: up to 16 weeks
trough serum drug concentration at steady state (Ctrough,ss)
Time frame: up to 16 weeks
Disease-free survival (DFS)
Time frame: up to 12 months
Adverse events (AEs); Serious adverse events (SAEs); Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions)
Time frame: From enrollment to the end of 90-day safety follow-up (up to 15 months)
Number of participants with abnormal vital signs, abnormal physical examination findings, abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers) or abnormal 12-lead ECG readings.
Time frame: From enrollment to the end of 30-day safety follow-up (up to 13 months)
Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb)
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX18 and OPDIVO® in people with Esophageal and/or Cardia Cancer and Melanoma, run by Shanghai Henlius Biotech at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chang Chen (+86 138 1686 9003, chenthoracic@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-28d (time frame: From time 0 to 28 days after the 1st dose(4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.