A Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Enlonstobart, With or Without SYS6010 as Adjuvant Therapy, in Participants With Pathologically Residual Esophageal Squamous Cell Carcinoma Following Complete Surgical Resection
NCT07924111, Phase 3, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Enlonstobart, With or Without SYS6010 as Adjuvant Therapy, in Participants With Pathologically Residual Esophageal Squamous Cell Carcinoma Following Complete Surgical Resection | ClinicalTrials.gov |
| NCT number | NCT07924111 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 585 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | CSPC Megalith Biopharmaceutical Co.,Ltd. | ClinicalTrials.gov |
| Conditions | Esophageal Squamous Cell Carcinoma | ClinicalTrials.gov |
| Interventions | SYS6010, SG001, SG001 placebo-mimicking, SYS6010 placebo-mimicking | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | DFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months | Disease Free Surviva Arm1 vs Arm3 Arm2 vs Arm3 | ClinicalTrials.gov |
| Secondary | OS ：Description: Overall survival | From date of randomization until the date of death from any cause, assessed up to 60 months. | Overall survival | ClinicalTrials.gov |
| Secondary | DMFS | From date of randomization until the date of first documented distant recurrence/distant metastasis or date of death from any cause, whichever came first, assessed up to 60 months. | Distant Metastasis-Free Survival | ClinicalTrials.gov |
| Secondary | Serum concentrations of toxin-bound antibodies for SYS6010 | From first dose of treatment to 30 days after the last dose of treatment. | Serum concentrations of toxin-bound antibodies following single and multiple doses of SYS6010 | ClinicalTrials.gov |
| Secondary | Plasma concentration of SG001 following single and multiple doses of SG001 | From first dose of treatment to 30 days after the last dose of treatment. | Plasma concentration of SG001 following single and multiple doses of SG001 | ClinicalTrials.gov |
| Secondary | Quality of life indicators assessed using the EORTC QLQ-C30; | Evaluated during the screening period (Day -28 to Day 1)，during the treatment period (at each tumor assessment), and at the End of Treatment visit. | ClinicalTrials.gov | |
| Secondary | mmunogenicity: incidence and titers of ADA for SYS6010 and SG001, incidence of neutralizing antibodies (if applicable). | From first dose of treatment to 30 days after the last dose of treatment. | ClinicalTrials.gov | |
| Secondary | AE | From first dose of treatment to 90 days after the last dose of treatment. | Incidence and severity of adverse events | ClinicalTrials.gov |
| Secondary | Serum concentrations of total antibodies for SYS6010; | From first dose of treatment to 30 days after the last dose of treatment. | Serum concentrations of total antibodies following single and multiple doses of SYS6010. | ClinicalTrials.gov |
| Secondary | Plasma concentration of SG001 following single and multiple doses of SG001; | From first dose of treatment to 30 days after the last dose of treatment. | Serum concentrations of JS-1 following single and multiple doses of SYS6010. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)