Pancreatic Adenocarcinoma ResectableADAPT-MRDNCT06966440
Adjuvant Pancreatic Therapy Guided by MRD
A study testing circulating tumor DNA (ctDNA)-based MRD and adjuvant chemotherapy regimens in people with Pancreatic Adenocarcinoma Resectable, run by Ruijin Hospital at 1 site in China.
Trial summary
Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Adenocarcinoma Resectable
- What is being tested?
- circulating tumor DNA (ctDNA)-based MRD and adjuvant chemotherapy regimens
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 856 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2030
- Phase
- Interventional
- 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
- Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule
- Male or female aged 18-75 years at the time of ICF signing.
- Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.
- Time between surgery and randomization ≤ 12 weeks.
- ECOG PS 0-2.
- Fully recovered from surgery and able to receive adjuvant chemotherapy.
- Availability of sufficient tumor tissue for MRD testing.
- Patients with reproductive potential (female patients: must have entered the study after the menstrual period and with a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one used by the patient and one by their partner) during the study and for 4 months (for females) or 6 months (for males) after the last study treatment.
Who cannot join
- Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.
- Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate/severe renal impairment (GFR < 30 ml/min) calculated using the Cockcroft-Gault equation. b) Absolute neutrophil count < 1.5 × 10^9/L. c) Platelet count < 100 × 10^9/L. d) Hemoglobin < 90 g/L. e) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 2.5 × the upper limit of normal.
- Pregnant or breastfeeding women.
- Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B, hepatitis C, HIV, etc.), which the investigator deems unsuitable for participation in the study or likely to affect compliance with the study protocol.
- Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin)
- Other conditions that the investigator deems 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
Ruijing Hospital
Shanghai
Baiyong Shen, Dr, 13901943778, shenby@shsmu.edu.cn
Baiyong Shen, Dr. Prof.
About this study
Official title: Assessing the Impact of Ct-DNA MRD-Guided Adjuvant Therapy on Outcomes in Resectable Pancreatic Cancer
Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. This study will explore the application of ctDNA MRD in guiding adjuvant therapy in these patients.
This prospective, randomized, interventional trial will evaluate a ct-DNA MRD-guided adjuvant therapy strategy in PAAD patients who have undergone radical resection at our institution. Prior to adjuvant chemotherapy, patients will be randomized (1:1) to either the experimental arm (Arm A) or the control arm (Arm B). Arm A will receive ct-DNA MRD-guided therapy, while Arm B will receive non-ctDNA-driven standard of care post-operative adjuvant therapy.
Read more
In Arm A, patients will receive a physician-selected, guideline-recommended adjuvant therapy regimen in 12-week cycles. ctDNA MRD will be assessed before the end of first cycle and at weeks 8 and 11. If two consecutive post-treatment MRD tests are negative, therapy will be "de-escalated" (discontinued) with regular follow-up as determined by the clinician. Otherwise, another treatment cycle will be administered, with the same MRD assessment. Following the second cycle, patients without two negative MRD results (only tested at week 8 and week 11 within each cycle) will "escalate" to a longer duration of chemotherapy (comparing to the 6-month standard of care) at the clinician's discretion. Treatment will continue until disease progression, intolerance, or study termination.
Arm B will receive standard post-operative adjuvant therapy for a duration recommended by CSCO guidelines (typically 6 months), followed by regular follow-up every 8 weeks.
The primary endpoint is to compare the prognosis, tolerability, and treatment completion rates between the two arms.
Read the detailed description
In pancreatic cancer, circulating tumor DNA (ctDNA) carries tumor-specific mutations (e.g., KRAS, TP53), which can be tracked using next-generation sequencing (NGS) technology to detect minimal residual disease (MRD) after surgery. Previous observational studies suggest that ctDNA-positive patients have a significantly higher risk of postoperative recurrence. In the MRD window (2-12 weeks post-surgery), the median disease-free survival (DFS) for ctDNA-positive patients was only 6.37 months, compared to 33.31 months for ctDNA-negative patients (HR=5.45), indicating that ctDNA-positive patients may require intensified treatment. Furthermore, patients with persistent ctDNA positivity after completing adjuvant chemotherapy (e.g., gemcitabine) still have a high recurrence rate (70%-90%), suggesting the need for alternative treatment strategies.
In a previous study (NCT05479708) evaluating postoperative MRD detection using plasma ctDNA to assess survival benefits and optimize adjuvant chemotherapy strategies in resectable pancreatic cancer patients, we found that MRD-positive patients at 4-8 weeks post-surgery (Landmark MRD) had a higher risk of recurrence. Analysis from Landmark MRD to 36 weeks post-treatment showed that patients who converted from positive to negative MRD status (MRD clearance) had a significantly lower risk of recurrence compared to those who remained positive and those who converted from negative to positive, and MRD clearance was associated with significantly improved overall survival (OS).
Given the significant trauma of pancreatic surgery and the often poor postoperative physical condition of patients, the optimal adjuvant chemotherapy regimen (single-agent/combination, duration, initiation time, etc.) that balances patient recovery and recurrence control remains unclear. Serum biomarker CA 19-9 is commonly used to assess prognosis in pancreatic cancer but is not a reliable predictor of adjuvant therapy efficacy. Imaging methods such as CT/MRI are often used to assess residual tumor or recurrence risk, but their sensitivity and specificity are limited, making it difficult to accurately evaluate real-time tumor burden. Therefore, we designed a prospective, randomized, interventional clinical trial based on ctDNA MRD to guide adjuvant chemotherapy decisions in patients with radically resected pancreatic cancer. The aim is to evaluate whether a ctDNA-guided treatment approach can reduce the use of adjuvant chemotherapy in low-risk patients without increasing recurrence risk, while intensifying treatment in high-risk patients to improve prognosis.
A ctDNA MRD-guided adjuvant therapy approach can allow patients to receive individualized adjuvant treatment. When ctDNA MRD test results are negative, adjuvant chemotherapy can be stopped with active follow-up. This can ensure that clinical benefits are not compromised while avoiding unnecessary chemotherapy. In cases where ctDNA MRD remains positive, continuing treatment can provide patients with more intensive therapy and potentially lead to better prognoses.
- Conditions
- Pancreatic Adenocarcinoma Resectable
- Being tested
- circulating tumor DNA (ctDNA)-based MRD, adjuvant chemotherapy regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circulating tumor DNA (ctDNA)-based MRDDiagnostic test
Also called MinerVa
MRD testing will be performed before the start of the first treatment cycle, and at weeks 8 and 11 of each subsequent cycle. MinerVa Prime is a tumor-informed MRD assay based on a fixed panel spanning 769 cancer-related genes.
adjuvant chemotherapy regimensDrug
Patients will be administered with appropriate adjuvant chemotherapy regimens including but are not limited to: GEM monotherapy/adjustable GEM monotherapy, S-1 monotherapy/adjustable S-1 monotherapy, fluorouracil monotherapy/adjustable fluorouracil monotherapy, GEM plus CAP regimen/adjustable GEM plus CAP regimen, mFOLFIRINOX regimen, GEM plus nab-paclitaxel regimen/adjustable GEM plus nab-paclitaxel regimen.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: MRD-guided adjuvant treatment | Experimental | In the experimental group, patients will receive a guideline-recommended adjuvant therapy regimen chosen by their physician, with each treatment cycle lasting 12 weeks. MRD testing will be performed before the start of the first treatment cycle, and at weeks 8 and 11 after the start of treatment. If two consecutive MRD tests after the start of treatment are negative, treatment will be discontinued, and the patient will undergo regular follow-up only. Otherwise, another treatment cycle will be added. Starting from the second cycle, MRD testing will only be performed at weeks 8 and 11 of each cycle. If two consecutive MRD tests are negative, treatment will be discontinued, and the patient will undergo regular follow-up (every 8 weeks). Otherwise, treatment cycles will continue until disease progression, patient intolerance to treatment, or study termination. Receives: Diagnostic Test: circulating tumor DNA (ctDNA)-based MRD; Drug: adjuvant chemotherapy regimens |
| Arm B: non-MRD-driven, standard of care adjuvant treatment | Placebo comparator | The control group will receive standard post-operative adjuvant therapy (according to CSCO guideline-recommended treatment duration, generally 6 months) followed by regular follow-up (every 8 weeks). Receives: Drug: adjuvant chemotherapy regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
To evaluate the impact of ct-DNA MRD-guided adjuvant therapy on disease-free survival (DFS), defined as the proportion of patients alive without objectively documented disease progression from the time of randomization until the 36th month.
Measured: From the time of randomization up to three years
Secondary outcomes (3)
Overall survival (OS)
To evaluate the impact of ct-DNA MRD-guided adjuvant therapy on overall survival (OS), defined as the proportion of patients alive from the time of randomization until the 36th month (3-year OS rate) or until the 60th month(5-years OS rate).
Measured: From the time of randomization until the 36th month (3-year OS rate) or until the 60th month(5-years OS rate)
Adjuvant chemotherapy completion rate
Adjuvant chemotherapy completion rate, defined in the experimental group (arm A) as the proportion of patients completing 1-cycle, 2-cycle, 3-cycle, or 4-cycle treatment based on MRD results (each cycle is about 12 weeks), and in the control group (arm B) as the proportion of patients completing the prescribed chemotherapy duration (generally 2-cycle treatment, about 24 weeks).
Measured: From the time of randomization to the end of treatment (arm A: 12 weeks, 24 weeks, 36 weeks, or 48 weeks; arm B: 24 weeks)
Adverse events (AE) and serious adverse events (SAE) rates
Incidence of AE and SAE assessed via NCI CTCAE version 5.0 in the two treatment modalities.
Definition of AE Possible adverse events include: drug-related peripheral sensory neuropathy, diarrhea, neutropenia, thrombocytopenia, nausea, vomiting, mucositis, fatigue, and hand-foot syndrome; as well as puncture site infections related to blood draws during the trial.
Definition of SAE
Possible serious adverse events include:
- Death of the patient;
- Life-threatening adverse events, such as Grade 4 non-hematologic toxicity or Grade 4 hematologic toxicity accompanied by fever and bleeding;
- Any adverse event requiring hospitalization or prolongation of existing hospitalization;
- Irreversible adverse events;
- Unexpected adverse events not listed in the drug label that may impact the continuation of the study.
Measured: From the time of randomization until the date of first recorded adverse events or serious adverse events as mentioned above, assessed up to 60 months (5-years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma ResectableStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 856 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, BAIYONG SHEN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966440
- Sponsor's protocol ID
- S-C2504015-PC
- Acronym
- ADAPT-MRD
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xia L, Pu Q, Kang R, Mei J, Li L, Yang Y, Deng S, Feng G, Deng Y, Gan F, Lin Y, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Chen W, Li Q, Du B, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen Y, Shen S, Chen L, Xie D, Liu L. Dynamic ctDNA informs whole-course postoperative precise management of NSCLC (LUNGCA study). J Natl Cancer Inst. 2025 Jul 1;117(7):1474-1484. doi: 10.1093/jnci/djaf061.
PubMed 40131728Xia L, Mei J, Kang R, Deng S, Chen Y, Yang Y, Feng G, Deng Y, Gan F, Lin Y, Pu Q, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Li Q, He J, Chen W, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen L, Liu L. Perioperative ctDNA-Based Molecular Residual Disease Detection for Non-Small Cell Lung Cancer: A Prospective Multicenter Cohort Study (LUNGCA-1). Clin Cancer Res. 2022 Aug 2;28(15):3308-3317. doi: 10.1158/1078-0432.CCR-21-3044.
PubMed 34844976
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Ct-DNA MRD-Guided Adjuvant Therapy on Outcomes in Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06966440
- Acronym / sponsor ID
- ADAPT-MRD / S-C2504015-PC
- Conditions
- Pancreatic Adenocarcinoma Resectable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 856 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- GeneCast Biotechnology Co., Ltd.
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 11 May 2025 (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.
Pancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. This study will explore the application of ctDNA MRD in guiding adjuvant therapy in these patients.
This prospective, randomized, interventional trial will evaluate a ct-DNA MRD-guided adjuvant therapy strategy in PAAD patients who have undergone radical resection at our institution. Prior to adjuvant chemotherapy, patients will be randomized (1:1) to either the experimental arm (Arm A) or the control arm (Arm B). Arm A will receive ct-DNA MRD-guided therapy, while Arm B will receive non-ctDNA-driven standard of care post-operative adjuvant therapy.
In Arm A, patients will receive a physician-selected, guideline-recommended adjuvant therapy regimen in 12-week cycles. ctDNA MRD will be assessed before the end of first cycle and at weeks 8 and 11. If two consecutive post-treatment MRD tests are negative, therapy will be "de-escalated" (discontinued) with regular follow-up as determined by the clinician. Otherwise, another treatment cycle will be administered, with the same MRD assessment. Following the second cycle, patients without two negative MRD results (only tested at week 8 and week 11 within each cycle) will "escalate" to a longer duration of chemotherapy (comparing to the 6-month standard of care) at the clinician's discretion. Treatment will continue until disease progression, intolerance, or study termination.
Arm B will receive standard post-operative adjuvant therapy for a duration recommended by CSCO guidelines (typically 6 months), followed by regular follow-up every 8 weeks.
The primary endpoint is to compare the prognosis, tolerability, and treatment completion rates between the two arms.
Detailed description
In pancreatic cancer, circulating tumor DNA (ctDNA) carries tumor-specific mutations (e.g., KRAS, TP53), which can be tracked using next-generation sequencing (NGS) technology to detect minimal residual disease (MRD) after surgery. Previous observational studies suggest that ctDNA-positive patients have a significantly higher risk of postoperative recurrence. In the MRD window (2-12 weeks post-surgery), the median disease-free survival (DFS) for ctDNA-positive patients was only 6.37 months, compared to 33.31 months for ctDNA-negative patients (HR=5.45), indicating that ctDNA-positive patients may require intensified treatment. Furthermore, patients with persistent ctDNA positivity after completing adjuvant chemotherapy (e.g., gemcitabine) still have a high recurrence rate (70%-90%), suggesting the need for alternative treatment strategies.
In a previous study (NCT05479708) evaluating postoperative MRD detection using plasma ctDNA to assess survival benefits and optimize adjuvant chemotherapy strategies in resectable pancreatic cancer patients, we found that MRD-positive patients at 4-8 weeks post-surgery (Landmark MRD) had a higher risk of recurrence. Analysis from Landmark MRD to 36 weeks post-treatment showed that patients who converted from positive to negative MRD status (MRD clearance) had a significantly lower risk of recurrence compared to those who remained positive and those who converted from negative to positive, and MRD clearance was associated with significantly improved overall survival (OS).
Given the significant trauma of pancreatic surgery and the often poor postoperative physical condition of patients, the optimal adjuvant chemotherapy regimen (single-agent/combination, duration, initiation time, etc.) that balances patient recovery and recurrence control remains unclear. Serum biomarker CA 19-9 is commonly used to assess prognosis in pancreatic cancer but is not a reliable predictor of adjuvant therapy efficacy. Imaging methods such as CT/MRI are often used to assess residual tumor or recurrence risk, but their sensitivity and specificity are limited, making it difficult to accurately evaluate real-time tumor burden. Therefore, we designed a prospective, randomized, interventional clinical trial based on ctDNA MRD to guide adjuvant chemotherapy decisions in patients with radically resected pancreatic cancer. The aim is to evaluate whether a ctDNA-guided treatment approach can reduce the use of adjuvant chemotherapy in low-risk patients without increasing recurrence risk, while intensifying treatment in high-risk patients to improve prognosis.
A ctDNA MRD-guided adjuvant therapy approach can allow patients to receive individualized adjuvant treatment. When ctDNA MRD test results are negative, adjuvant chemotherapy can be stopped with active follow-up. This can ensure that clinical benefits are not compromised while avoiding unnecessary chemotherapy. In cases where ctDNA MRD remains positive, continuing treatment can provide patients with more intensive therapy and potentially lead to better prognoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: MRD-guided adjuvant treatment | Experimental | Diagnostic Test: circulating tumor DNA (ctDNA)-based MRD, Drug: adjuvant chemotherapy regimensIn the experimental group, patients will receive a guideline-recommended adjuvant therapy regimen chosen by their physician, with each treatment cycle lasting 12 weeks. MRD testing will be performed before the start of the first treatment cycle, and at weeks 8 and 11 after the start of treatment. If two consecutive MRD tests after the start of treatment are negative, treatment will be discontinued, and the patient will undergo regular follow-up only. Otherwise, another treatment cycle will be added. Starting from the second cycle, MRD testing will only be performed at weeks 8 and 11 of each cycle. If two consecutive MRD tests are negative, treatment will be discontinued, and the patient will undergo regular follow-up (every 8 weeks). Otherwise, treatment cycles will continue until disease progression, patient intolerance to treatment, or study termination. |
| Arm B: non-MRD-driven, standard of care adjuvant treatment | Placebo comparator | Drug: adjuvant chemotherapy regimensThe control group will receive standard post-operative adjuvant therapy (according to CSCO guideline-recommended treatment duration, generally 6 months) followed by regular follow-up (every 8 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of providing written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule
- Male or female aged 18-75 years at the time of ICF signing.
- Histologically confirmed pancreatic ductal adenocarcinoma, Stage I-III, and has undergone R0 resection.
- Time between surgery and randomization ≤ 12 weeks.
- ECOG PS 0-2.
Key exclusion criteria (6 listed)
- Other types of non-ductal pancreatic tumors, including neuroendocrine tumors or acinar cell carcinoma, cystadenocarcinoma, and ampullary carcinoma.
- Hepatic or renal dysfunction as follows, or if the investigator considers adjuvant chemotherapy to be clearly contraindicated: a) Moderate/severe renal impairment (GFR < 30 ml/min) calculated using the Cockcroft-Gault equation. b) Absolute neutrophil count < 1.5 × 10^9/L. c) Platelet count < 100 × 10^9/L. d) Hemoglobin < 90 g/L. e) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 2.5 × the upper limit of normal.
- Pregnant or breastfeeding women.
- Any serious or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, active infection (including hepatitis B, hepatitis C, HIV, etc.), which the investigator deems unsuitable for participation in the study or likely to affect compliance with the study protocol.
- Concurrent presence of another malignancy or a history of malignancy (except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin)
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)-based MRDAlso: MinerVaMRD testing will be performed before the start of the first treatment cycle, and at weeks 8 and 11 of each subsequent cycle. MinerVa Prime is a tumor-informed MRD assay based on a fixed panel spanning 769 cancer-related genes. | Diagnostic test | Arm A: MRD-guided adjuvant treatment |
| adjuvant chemotherapy regimensPatients will be administered with appropriate adjuvant chemotherapy regimens including but are not limited to: GEM monotherapy/adjustable GEM monotherapy, S-1 monotherapy/adjustable S-1 monotherapy, fluorouracil monotherapy/adjustable fluorouracil monotherapy, GEM plus CAP regimen/adjustable GEM plus CAP regimen, mFOLFIRINOX regimen, GEM plus nab-paclitaxel regimen/adjustable GEM plus nab-paclitaxel regimen. | Drug | Arm A: MRD-guided adjuvant treatment, Arm B: non-MRD-driven, standard of care adjuvant treatment |
Primary outcome
Disease free survival (DFS)
Time frame: From the time of randomization up to three years
To evaluate the impact of ct-DNA MRD-guided adjuvant therapy on disease-free survival (DFS), defined as the proportion of patients alive without objectively documented disease progression from the time of randomization until the 36th month.
3 secondary outcomes
Overall survival (OS)
Time frame: From the time of randomization until the 36th month (3-year OS rate) or until the 60th month(5-years OS rate)
Adjuvant chemotherapy completion rate
Time frame: From the time of randomization to the end of treatment (arm A: 12 weeks, 24 weeks, 36 weeks, or 48 weeks; arm B: 24 weeks)
Adverse events (AE) and serious adverse events (SAE) rates
Time frame: From the time of randomization until the date of first recorded adverse events or serious adverse events as mentioned above, assessed up to 60 months (5-years)
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 15 Jul 2025.
- Results publication: PubMed 40131728Xia L, Pu Q, Kang R, Mei J, Li L, Yang Y, Deng S, Feng G, Deng Y, Gan F, Lin Y, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Chen W, Li Q, Du B, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen Y, Shen S, Chen L, Xie D, Liu L. Dynamic ctDNA informs whole-course postoperative precise management of NSCLC (LUNGCA study). J Natl Cancer Inst. 2025 Jul 1;117(7):1474-1484. doi: 10.1093/jnci/djaf061.
- Results publication: PubMed 34844976Xia L, Mei J, Kang R, Deng S, Chen Y, Yang Y, Feng G, Deng Y, Gan F, Lin Y, Pu Q, Ma L, Lin F, Yuan Y, Hu Y, Guo C, Liao H, Liu C, Zhu Y, Wang W, Liu Z, Xu Y, Li K, Li C, Li Q, He J, Chen W, Zhang X, Kou Y, Wang Y, Wu Z, Che G, Chen L, Liu L. Perioperative ctDNA-Based Molecular Residual Disease Detection for Non-Small Cell Lung Cancer: A Prospective Multicenter Cohort Study (LUNGCA-1). Clin Cancer Res. 2022 Aug 2;28(15):3308-3317. doi: 10.1158/1078-0432.CCR-21-3044.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circulating tumor DNA (ctDNA)-based MRD and adjuvant chemotherapy regimens in people with Pancreatic Adenocarcinoma Resectable, run by Ruijin Hospital 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 8 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 15 Jul 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Baiyong Shen, Dr (008613901943778, shenby@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: From the time of randomization up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06966440, which also lists 2 linked publications.
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 15 Jul 2025.