Trial · NCT04297995
Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors
NCT04297995, Phase 2, Unknown, Shanghai Henlius Biotech
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors. Trials, record NCT04297995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04297995
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Efficacy and Safety of HLX10 in Combination With HLX07 in Patients With Advanced Head and Neck Tumors
- NCT number
- NCT04297995
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 131 participants, estimated
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Interventions
- HLX10, HLX07, HLX07 placebo, Cisplatin/Carboplatin, 5-FU
- First posted
- 2020-03-06
- Last updated
- 2023-08-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part1: Efficacy-ORR | at 16 weeks after first dose | Objective Response Rate (ORR) |
| Primary | Part1: Safety-adverse event profile | up to one year | The proportion of patients suffered from drug related toxicities. |
| Primary | Part2: Efficacy-ORR (IRRC) | at 3 months after first dose | Objective Response Rate (ORR) assessed by the Independent Radiological Review Committee (IRRC) per RECIST v1.1. |
| Secondary | Efficacy-Best ORR | up to one year | Best response rate (Best ORR) |
| Secondary | Efficacy-PFS | up to one year | Progression-free survival (PFS) |
| Secondary | Efficacy-OS | up to one year | Overall survival (OS) |
| Secondary | The number of presence patients that develop of anti-durg antibody (immunogenicity). | up to one year | |
| Secondary | maximum concentration (Cmax) | up to one year | |
| Secondary | trough concentration (Ctrough) | up to one year | |
| Secondary | half-life (T1/2) | up to one year |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40932107 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04297995
GET https://conductscience.org/api/trials/v1/NCT04297995/registered