Gastric CancerPhase 2NCT07517107
Dynamic Circulating Tumor DNA Monitoring to Guide Systemic Therapy in Gastric Cancer
A Phase 2 study testing Circulating Tumor DNA (ctDNA) Analysis and Standard Systemic Therapy for Gastric Cancer in people with Gastric Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to evaluate the clinical value of circulating tumor DNA (ctDNA) as a minimally invasive biomarker for monitoring treatment response and guiding systemic therapy in patients with gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Circulating Tumor DNA (ctDNA) Analysis and Standard Systemic Therapy for Gastric Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Age ≥18 years. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function within 7 days prior to enrollment, including:
- Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥80 × 10⁹/L Hemoglobin ≥80 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) AST and ALT ≤2.5 × ULN (≤5 × ULN in case of liver metastases) Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min Serum albumin ≥30 g/L Estimated life expectancy ≥3 months. Willingness to provide blood samples for circulating tumor DNA (ctDNA) analysis.
- Signed written informed consent prior to any study-related procedures.
Show all 16Show fewer
- Cohort-Specific Inclusion Criteria:
- Neoadjuvant/Conversion Cohort:
- 8. Planned to receive neoadjuvant or conversion systemic therapy followed by potential surgery.
- 9. Locally advanced (T3-T4a and/or N+, M0) or oligometastatic disease (≤1 metastatic organ and ≤5 lesions) considered potentially resectable after systemic therapy.
- 10. No prior systemic therapy for gastric cancer.
- Adjuvant Cohort:
- 11. Completion of curative-intent surgery for gastric cancer. 12. Pathological stage II-III disease without distant metastasis. 13. Planned to receive standard adjuvant chemotherapy (e.g., XELOX or SOX).
- Advanced Disease Cohort:
- 14. Unresectable or metastatic disease not amenable to curative surgery. 15. Planned to receive systemic therapy, including chemotherapy with or without immunotherapy, as first-line or later-line treatment.
- 16. At least one measurable lesion according to RECIST v1.1.
Who cannot join
- -
- History of another malignancy within 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer.
- Uncontrolled central nervous system metastases or primary brain tumors.
- Severe or uncontrolled comorbidities, including but not limited to:
- Unstable cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure) Severe infection Active disseminated intravascular coagulation Significant bleeding tendency Significant organ dysfunction that, in the investigator's judgment, would compromise patient safety.
- Symptomatic pleural effusion or ascites requiring intervention. Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Weijian Guo, 02164175590, guoweijian1@hotmail.com
About this study
Official title: A Prospective Phase II Study of Dynamic Circulating Tumor DNA to Predict and Guide Systemic Treatment in Patients With Gastric Cancer
This study aims to evaluate the clinical value of circulating tumor DNA (ctDNA) as a minimally invasive biomarker for monitoring treatment response and guiding systemic therapy in patients with gastric or gastroesophageal junction adenocarcinoma.
Gastric cancer is often diagnosed at an advanced stage and shows substantial biological heterogeneity. Current treatment decisions mainly rely on imaging and clinical assessment, which may not reflect early molecular changes or minimal residual disease. Circulating tumor DNA, released from tumor cells into the bloodstream, can provide real-time information on tumor burden and treatment response through simple blood sampling.
Read more
This is a prospective, open-label, phase II exploratory study conducted at a single center. Patients will be enrolled into three clinical cohorts according to their treatment stage: (1) neoadjuvant or conversion therapy cohort, (2) adjuvant therapy cohort after curative surgery, and (3) advanced or metastatic disease cohort receiving systemic therapy. Blood samples for ctDNA analysis will be collected before treatment and at predefined time points during treatment.
The study will assess whether changes in ctDNA levels, including ctDNA clearance or reduction, are associated with treatment response, recurrence risk, and survival outcomes. In selected validation phases, treatment strategies may be adjusted based on ctDNA results, while all treatments remain within standard guideline-recommended regimens.
The results of this study may help determine whether ctDNA can be used as a practical tool to improve treatment monitoring and support more personalized management of gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Circulating Tumor DNA (ctDNA) Analysis, Standard Systemic Therapy for Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating Tumor DNA (ctDNA) AnalysisDiagnostic test
Plasma circulating tumor DNA (ctDNA) will be analyzed using a targeted next-generation sequencing panel to assess tumor-specific genetic alterations. Blood samples will be collected at predefined time points during treatment. ctDNA dynamics, including clearance or changes in mutation allele frequency, will be used to evaluate molecular response and guide treatment decisions within standard-of-care options.
Standard Systemic Therapy for Gastric CancerDrug
Participants will receive guideline-recommended systemic treatment according to disease stage and clinical practice, including neoadjuvant or conversion therapy, adjuvant chemotherapy, or systemic therapy for advanced disease. Treatment regimens may include fluoropyrimidine- and platinum-based chemotherapy, with or without PD-1 inhibitors or other standard agents. All treatments are administered according to standard-of-care and are not investigational.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-Guided Standard Treatment Arm | Experimental | Participants in this arm will receive guideline-recommended systemic treatment according to their disease stage, including neoadjuvant or conversion therapy, adjuvant chemotherapy, or systemic therapy for advanced disease. Plasma circulating tumor DNA (ctDNA) will be collected at predefined time points during treatment. Treatment decisions, including continuation or adjustment of therapy in selected phases, will be guided by predefined ctDNA molecular response criteria within standard-of-care options. No investigational drugs will be used. Receives: Diagnostic Test: Circulating Tumor DNA (ctDNA) Analysis; Drug: Standard Systemic Therapy for Gastric Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by investigators.
Measured: Up to 24 months
Secondary outcomes (6)
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from study enrollment to the first documentation of disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to 36 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from study enrollment to death from any cause.
Measured: Up to 36 months
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Measured: Up to 24 months
Recurrence-Free Survival (RFS)
Recurrence-free survival (RFS) is defined as the time from study enrollment (or surgery for applicable patients) to the first documentation of disease recurrence.
Measured: Up to 36 months
Pathological Complete Response Rate (pCR)
Pathological complete response (pCR) is defined as the absence of residual tumor cells in the resected specimen after neoadjuvant or conversion therapy.
Measured: At time of surgery (approximately within 6 months)
Safety and Tolerability
Incidence and severity of adverse events assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Up to 36 months
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 start1 Jan 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
- Investigators
- Weijian Guo, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517107
- Sponsor's protocol ID
- GC-CTDNA2025
- Status last verified
- Dec 2025
- First submitted
- 1 Apr 2026
- Last updated
- 8 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Dynamic Circulating Tumor DNA to Predict and Guide Systemic Treatment in Patients With Gastric Cancer
- ClinicalTrials.gov ID
- NCT07517107
- Acronym / sponsor ID
- GC-CTDNA2025
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (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 study aims to evaluate the clinical value of circulating tumor DNA (ctDNA) as a minimally invasive biomarker for monitoring treatment response and guiding systemic therapy in patients with gastric or gastroesophageal junction adenocarcinoma.
Gastric cancer is often diagnosed at an advanced stage and shows substantial biological heterogeneity. Current treatment decisions mainly rely on imaging and clinical assessment, which may not reflect early molecular changes or minimal residual disease. Circulating tumor DNA, released from tumor cells into the bloodstream, can provide real-time information on tumor burden and treatment response through simple blood sampling.
This is a prospective, open-label, phase II exploratory study conducted at a single center. Patients will be enrolled into three clinical cohorts according to their treatment stage: (1) neoadjuvant or conversion therapy cohort, (2) adjuvant therapy cohort after curative surgery, and (3) advanced or metastatic disease cohort receiving systemic therapy. Blood samples for ctDNA analysis will be collected before treatment and at predefined time points during treatment.
The study will assess whether changes in ctDNA levels, including ctDNA clearance or reduction, are associated with treatment response, recurrence risk, and survival outcomes. In selected validation phases, treatment strategies may be adjusted based on ctDNA results, while all treatments remain within standard guideline-recommended regimens.
The results of this study may help determine whether ctDNA can be used as a practical tool to improve treatment monitoring and support more personalized management of gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA-Guided Standard Treatment Arm | Experimental | Diagnostic Test: Circulating Tumor DNA (ctDNA) Analysis, Drug: Standard Systemic Therapy for Gastric CancerParticipants in this arm will receive guideline-recommended systemic treatment according to their disease stage, including neoadjuvant or conversion therapy, adjuvant chemotherapy, or systemic therapy for advanced disease. Plasma circulating tumor DNA (ctDNA) will be collected at predefined time points during treatment. Treatment decisions, including continuation or adjustment of therapy in selected phases, will be guided by predefined ctDNA molecular response criteria within standard-of-care options. No investigational drugs will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- -
- Age ≥18 years. Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Absolute neutrophil count ≥1.5 × 10⁹/L Platelet count ≥80 × 10⁹/L Hemoglobin ≥80 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) AST and ALT ≤2.5 × ULN (≤5 × ULN in case of liver metastases) Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min Serum albumin ≥30 g/L Estimated life expectancy ≥3 months. Willingness to provide blood samples for circulating tumor DNA (ctDNA) analysis.
- Signed written informed consent prior to any study-related procedures.
Key exclusion criteria (6 listed)
- -
- History of another malignancy within 5 years, except for adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer.
- Uncontrolled central nervous system metastases or primary brain tumors.
- Unstable cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure) Severe infection Active disseminated intravascular coagulation Significant bleeding tendency Significant organ dysfunction that, in the investigator's judgment, would compromise patient safety.
- Symptomatic pleural effusion or ascites requiring intervention. Any condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
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 |
|---|---|---|
| Circulating Tumor DNA (ctDNA) AnalysisPlasma circulating tumor DNA (ctDNA) will be analyzed using a targeted next-generation sequencing panel to assess tumor-specific genetic alterations. Blood samples will be collected at predefined time points during treatment. ctDNA dynamics, including clearance or changes in mutation allele frequency, will be used to evaluate molecular response and guide treatment decisions within standard-of-care options. | Diagnostic test | ctDNA-Guided Standard Treatment Arm |
| Standard Systemic Therapy for Gastric CancerParticipants will receive guideline-recommended systemic treatment according to disease stage and clinical practice, including neoadjuvant or conversion therapy, adjuvant chemotherapy, or systemic therapy for advanced disease. Treatment regimens may include fluoropyrimidine- and platinum-based chemotherapy, with or without PD-1 inhibitors or other standard agents. All treatments are administered according to standard-of-care and are not investigational. | Drug | ctDNA-Guided Standard Treatment Arm |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months
Objective response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by investigators.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 24 months
Recurrence-Free Survival (RFS)
Time frame: Up to 36 months
Pathological Complete Response Rate (pCR)
Time frame: At time of surgery (approximately within 6 months)
Safety and Tolerability
Time frame: Up to 36 months
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 8 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Weijian Guo principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Circulating Tumor DNA (ctDNA) Analysis and Standard Systemic Therapy for Gastric Cancer in people with Gastric Cancer, run by Fudan University at 1 site 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 16 inclusion and 6 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 Weijian Guo (02164175590, guoweijian1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 months). 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 8 Apr 2026.