ctDNAPhase 2NCT07507916
Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing HLX10 and SOX Chemotherapy in people with ctDNA and Gastric Cancer, run by Fudan University.
Trial summary
This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ctDNA, Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- HLX10 and SOX Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.
- Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.
- Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.
- Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.
- HER2-negative disease.
- Adequate cardiac function and deemed suitable for curative-intent surgical resection. Patients with ischemic heart disease, valvular disease, or other significant cardiac conditions should undergo preoperative evaluation by a cardiologist if clinically indicated.
Show all 32Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment.
- Estimated life expectancy of at least 6 months.
- Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core antibody (HBcAb). If HBsAg-positive or HBcAb-positive, hepatitis B virus DNA (HBV-DNA) must be <1000 copies/mL, <200 IU/mL, or below the upper limit of normal (ULN) of the study center.
- Negative hepatitis C virus (HCV) antibody.
- Adequate organ function, defined as follows (without transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factors within 14 days prior to randomization):
- Hematologic function
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L Hepatic function
- Total bilirubin ≤ 1.5 × ULN
- ALT ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)
- AST ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)
- Alkaline phosphatase ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver and/or bone metastases)
- Albumin ≥ 25 g/L Renal function
- Creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-Gault formula) Coagulation function
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Prothrombin time (PT) ≤ 1.5 × ULN
- International normalized ratio (INR) ≤ 1.5 × ULN
- Female patients must meet one of the following:
- Postmenopausal (defined as ≥1 year without menstruation not due to other causes), or
- Surgically sterile (bilateral oophorectomy and/or hysterectomy), or
- Of childbearing potential and meeting all of the following:
- Negative serum pregnancy test within 7 days prior to enrollment;
- Agree to use highly effective contraception (annual failure rate <1%) or remain abstinent from signing the ICF until at least 120 days after the last dose of study drug and 6 months after the last dose of chemotherapy;
- Not breastfeeding.
- Male patients must agree to abstain from heterosexual intercourse or use effective contraception during chemotherapy and for at least 6 months after the last dose of chemotherapy, and for at least 120 days after the last dose of study drug, if their partner is of childbearing potential or pregnant.
Who cannot join
- History of another active malignancy within the past 5 years or concurrent malignancy, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
- Presence of distant metastasis (M1) from gastric cancer.
- Prior or planned organ or bone marrow transplantation.
- History of myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmia, including QTc prolongation (QTc ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula).
- New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography.
- Known human immunodeficiency virus (HIV) infection.
Show all 19Show fewer
- Active pulmonary tuberculosis.
- Current or prior interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction that may interfere with the assessment or management of suspected drug-related pulmonary toxicity.
- Known active or suspected autoimmune disease, except for patients with stable disease not requiring systemic immunosuppressive therapy at enrollment.
- Receipt of a live vaccine within 28 days prior to enrollment (seasonal influenza vaccines with inactivated virus are allowed).
- Requirement for systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 14 days prior to enrollment or during the study, except for:
- Topical or inhaled corticosteroids;
- Physiologic replacement therapy with prednisone ≤10 mg/day in the absence of active autoimmune disease.
- Active infection requiring systemic anti-infective therapy within 14 days prior to enrollment (prophylactic antibiotics, such as for urinary tract infection or chronic obstructive pulmonary disease, are allowed).
- Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Participation in another clinical study or receipt of investigational treatment within 14 days prior to initiation of this study.
- Known severe hypersensitivity to any monoclonal antibody or components of the study drugs.
- History of substance abuse or illicit drug use; patients who have stopped alcohol consumption may be enrolled.
- Any condition that, in the investigator's judgment, may increase the risk of study participation or interfere with study treatment, compliance, or evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynamic Circulating Tumor DNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma：A Phase 2 Clinical Trial
This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.
After curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk.
In this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.
Read the detailed description
This is a single-center, prospective, exploratory study designed to evaluate the feasibility and clinical value of using dynamic circulating tumor DNA (ctDNA) testing to guide postoperative adjuvant treatment in patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.
After curative-intent surgery, patients remain at risk of disease recurrence. Currently, postoperative adjuvant treatment decisions are mainly based on clinical and pathological factors, which may not fully reflect the presence of minimal residual disease. ctDNA is a blood-based biomarker that can detect small amounts of tumor-derived DNA and may provide additional information about recurrence risk after surgery.
In this study, ctDNA will be dynamically assessed at predefined perioperative and postoperative time points using peripheral blood samples. The study aims to explore the association between postoperative ctDNA status and disease outcomes, as well as the potential role of ctDNA monitoring in postoperative adjuvant treatment management.
The primary objective of this study is to evaluate disease-free survival at 1 year. Secondary objectives include assessment of survival outcomes, safety, and changes in ctDNA status over time. The results of this exploratory study are expected to provide preliminary evidence to support further clinical research on ctDNA-guided adjuvant treatment strategies in gastric cancer.
- Being tested
- HLX10, SOX Chemotherapy
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX10Drug
HLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment
SOX ChemotherapyDrug
SOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-Positive（after surgery） | Experimental | Patients with detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 in combination with SOX chemotherapy Receives: Drug: HLX10; Drug: SOX Chemotherapy |
| ctDNA-Negative（after surgery） | Experimental | Patients without detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 monotherapy Receives: Drug: HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year Disease-Free Survival rate
Disease-Free Survival rate at 1 year
Measured: Up to 1 year after surgery
Secondary outcomes (7)
Disease Control Rate
the proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Measured: During perioperative treatment
Major Pathological Response (MPR) Rate
the proportion of patients with ≤10% residual viable tumor cells in the resected tumor specimen, as assessed by pathological examination after surgery
Measured: At the time of surgery
3-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 3 years after surgery.
Measured: Up to 3 years after surgery
5-year Disease-Free Survival Rate
the proportion of patients who remain alive without disease recurrence or metastasis within 5 years after surgery.
Measured: Up to 5 years after surgery
Median Disease-Free Survival
Median disease-free survival (mDFS) is defined as the time from the date of surgery to the date of first documented local or distant recurrence, diagnosis of a new primary malignancy, or death from any cause, whichever occurs first. mDFS is the time point at which 50% of patients remain disease-free.
Measured: Up to 5 years after surgery
Overall Survival
the time from study enrollment to death from any cause.
Measured: Up to 5 years after enrollment
adverse events
Safety is assessed by the incidence, nature, and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Measured: From the first dose of study treatment up to 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ctDNAStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Dynamic circulating tumor DNA (ctDNA) assessments are performed at predefined perioperative and postoperative time points, and clinical outcomes are evaluated longitudinally during postoperative adjuvant treatment and follow-up.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Lu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507916
- Sponsor's protocol ID
- SOLIDS-07
- Other IDs
- Shanghai Cancer Center
- Status last verified
- Jan 2026
- First submitted
- 15 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Circulating Tumor DNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma：A Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT07507916
- Acronym / sponsor ID
- SOLIDS-07
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 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 single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.
After curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk.
In this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.
Detailed description
This is a single-center, prospective, exploratory study designed to evaluate the feasibility and clinical value of using dynamic circulating tumor DNA (ctDNA) testing to guide postoperative adjuvant treatment in patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.
After curative-intent surgery, patients remain at risk of disease recurrence. Currently, postoperative adjuvant treatment decisions are mainly based on clinical and pathological factors, which may not fully reflect the presence of minimal residual disease. ctDNA is a blood-based biomarker that can detect small amounts of tumor-derived DNA and may provide additional information about recurrence risk after surgery.
In this study, ctDNA will be dynamically assessed at predefined perioperative and postoperative time points using peripheral blood samples. The study aims to explore the association between postoperative ctDNA status and disease outcomes, as well as the potential role of ctDNA monitoring in postoperative adjuvant treatment management.
The primary objective of this study is to evaluate disease-free survival at 1 year. Secondary objectives include assessment of survival outcomes, safety, and changes in ctDNA status over time. The results of this exploratory study are expected to provide preliminary evidence to support further clinical research on ctDNA-guided adjuvant treatment strategies in gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dynamic circulating tumor DNA (ctDNA) assessments are performed at predefined perioperative and postoperative time points, and clinical outcomes are evaluated longitudinally during postoperative adjuvant treatment and follow-up.
| Arm | Type | Receives |
|---|---|---|
| ctDNA-Positive（after surgery） | Experimental | Drug: HLX10, Drug: SOX ChemotherapyPatients with detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 in combination with SOX chemotherapy |
| ctDNA-Negative（after surgery） | Experimental | Drug: HLX10Patients without detectable circulating tumor DNA (ctDNA) after surgery will receive adjuvant treatment with HLX10 monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.
- Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.
- Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.
- Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.
- HER2-negative disease.
Key exclusion criteria (19 listed)
- History of another active malignancy within the past 5 years or concurrent malignancy, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.
- Presence of distant metastasis (M1) from gastric cancer.
- Prior or planned organ or bone marrow transplantation.
- History of myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmia, including QTc prolongation (QTc ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula).
- New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography.
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 |
|---|---|---|
| HLX10HLX10 is a programmed death-1 (PD-1) monoclonal antibody administered as postoperative adjuvant treatment | Drug | ctDNA-Negative（after surgery）, ctDNA-Positive（after surgery） |
| SOX ChemotherapySOX chemotherapy consists of S-1 in combination with oxaliplatin and is administered as part of postoperative adjuvant treatment | Drug | ctDNA-Positive（after surgery） |
Primary outcome
1 year Disease-Free Survival rate
Time frame: Up to 1 year after surgery
Disease-Free Survival rate at 1 year
7 secondary outcomes
Disease Control Rate
Time frame: During perioperative treatment
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery
3-year Disease-Free Survival Rate
Time frame: Up to 3 years after surgery
5-year Disease-Free Survival Rate
Time frame: Up to 5 years after surgery
Median Disease-Free Survival
Time frame: Up to 5 years after surgery
Overall Survival
Time frame: Up to 5 years after enrollment
adverse events
Time frame: From the first dose of study treatment up to 90 days after the last dose
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 2 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for ctDNA
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
Breast Cancer, Metastatic Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX10 and SOX Chemotherapy in people with ctDNA and Gastric Cancer, run by Fudan University.
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 32 inclusion and 19 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: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jun Lu (18916871096, lujun@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year Disease-Free Survival rate (time frame: Up to 1 year after surgery). 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 2 Apr 2026.