A Phase 3 interventional study of SYS6010 and SG001 in Esophageal Squamous Cell Carcinoma, sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
This is 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.
This study is a randomized, double-blind, three-arm, placebo-controlled, multicenter Phase III trial designed to evaluate the efficacy and safety of SG001, with or without SYS6010, compared to placebo as adjuvant therapy following radical surgery with R0 resection but with pathological residual disease (ypT1-4aN0M0 or ypT0-4aN+M0) in patients with resectable Stage II -III esophageal squamous cell carcinoma who achieved R0 resection following curative surgery after neoadjuvant therap.
The study plans to enroll 585 participants who have previously undergone curative surgery for esophageal cancer, with R0 resection at surgery, pathologically confirmed failure to achieve pCR, and who have signed an informed consent form. Participants will be randomly assigned in a 2:2:1 ratio to the following groups in a double-blind manner: SG001 + SYS6010 vs. SG001 + placebo-mimicking SYS6010 vs. SG001 placebo-mimicking + placebo-mimicking SYS6010.
675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.
This study's planned enrollment of 585 is above the median of 64 across 563 interventional studies indexed under Esophageal Squamous Cell Carcinoma.
Browse Esophageal Squamous Cell Carcinoma studies →CSPC Megalith Biopharmaceutical Co.,Ltd. is the lead sponsor of 42 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With histologically/ confirmed esophageal squamous cell carcinoma that is clinically staged as stage II-III , therapy must be completed prior to randomization, followed by curative surgery for esophageal squamous cell carcinoma, and all of the following criteria must be met:
Neoadjuvant therapy includes: at least 2 cycles of platinum-based chemotherapy (± ) or chemoradiotherapy, with no clinically or radiologically confirmed disease progression during the neoadjuvant therapy phase.
Participants must have achieved R0 complete resection, with the surgery resulting in a tumor-free state and negative surgical margins.
Prior to randomization, the Center's Independent Pathology Review Committee (CPIRC) will evaluate the participant's postoperative pathology report (pathology report must be provided). Participants who do not achieve pathological complete response (non-pCR) and have pathological residual disease (ypT1-4aN0M0 or ypT0-4aN+M0) will have their pathology results assessed and confirmed by the Center's Independent Pathology Review Committee in cases of uncertain pathology (e.g., ypNx).
Postoperative adjuvant therapy must begin 4-16 weeks after curative surgery.;
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SYS6010 · Drug: SG001
Drug: SG001 · Drug: SYS6010 placebo-mimicking
Drug: SG001 placebo-mimicking · Drug: SYS6010 placebo-mimicking
SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker.
SG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody.
SG001 placebo-mimicking is a placebo mimicking of SG001
SYS6010 placebo-mimicking is a placebo mimicking of SYS6010
DFS
Disease Free Surviva Arm1 vs Arm3 Arm2 vs Arm3
Time frame: 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
OS ：Description: Overall survival
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months.
DMFS
Distant Metastasis-Free Survival
Time frame: 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.
Serum concentrations of toxin-bound antibodies for SYS6010
Serum concentrations of toxin-bound antibodies following single and multiple doses of SYS6010
Time frame: 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
Plasma concentration of SG001 following single and multiple doses of SG001
Time frame: From first dose of treatment to 30 days after the last dose of treatment.
Quality of life indicators assessed using the EORTC QLQ-C30;
Time frame: 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.
mmunogenicity: incidence and titers of ADA for SYS6010 and SG001, incidence of neutralizing antibodies (if applicable).
Time frame: From first dose of treatment to 30 days after the last dose of treatment.
AE
Incidence and severity of adverse events
Time frame: From first dose of treatment to 90 days after the last dose of treatment.
Serum concentrations of total antibodies for SYS6010;
Serum concentrations of total antibodies following single and multiple doses of SYS6010.
Time frame: 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;
Serum concentrations of JS-1 following single and multiple doses of SYS6010.
Time frame: From first dose of treatment to 30 days after the last dose of treatment.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Anti-EGFR Antibody-drug Conjugate CPO301 · Enlonstobart
Esophageal Squamous Cell Carcinoma →
CSPC Megalith Biopharmaceutical Co.,Ltd. →