Colorectal Neoplasms MalignantPhase 2NCT06778382
Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.
A Phase 2 study testing Oligometastasis Treatment in people with Colorectal Neoplasms Malignant, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms Malignant
- What is being tested?
- Oligometastasis Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to 1 Nov 2026
- 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
- Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:
- The patient has achieved No Evidence of Disease (NED) after undergoing EMR, surgery, radiofrequency ablation, or radiotherapy.
- NED has been maintained for ≥ 6 months.
- The patient has not received chemotherapy, or has only received postoperative adjuvant chemotherapy or first-line systemic therapy.
- Oligometastatic lung lesions (defined as 5 or fewer lesions) detected after ≥ 6 months of NED maintenance, eligible for destructive therapy.
- No prior radiotherapy to the lungs.
Show all 13Show fewer
- RECIST 1.1 criteria: The patient must have measurable lesions, defined as at least one nodal lesion with a longest diameter > 1.5 cm, or at least one nodal lesion > 1 cm with an accurately measurable pendulous diameter.
- ECOG performance status: ≤ 2 (Eastern Cooperative Oncology Group general condition score).
- The patient's expected survival must be ≥ 3 months.
- Adequate hematologic function: Absolute neutrophil count ≥ 1.6 x 10⁹/L, with no growth factor support for at least 7 days prior to testing.
- Normal organ function: The patient must be able to tolerate at least one of the local destructive treatments, as assessed by the corresponding department's physician, based on normal hepatic, renal, pulmonary, and cardiac function.
- Reproductive age: Female patients of childbearing potential must agree to use a reliable method of contraception with their partner from the time of informed consent until 1 year after treatment completion.
- The patient must have voluntarily provided informed consent to participate in the study.
Who cannot join
- First diagnosis of advanced colorectal cancer with metastatic disease.
- Multiple lung metastases (> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
- Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
- Previously received second-line or higher systemic treatment.
- Liver or kidney dysfunction: Alanine aminotransferase (ALT) > 3 times the upper limit of normal; Aspartate aminotransferase (AST) > 3 times the upper limit of normal; Total bilirubin (TBIL) > 2 times the upper limit of normal; Serum creatinine > 1.5 times the upper limit of normal.
- Elevated tumor marker: CEA ≥ 50 ng/mL.
Show all 14Show fewer
- Serious medical conditions that may interfere with the study (e.g., uncontrolled diabetes, gastric ulcers, severe cardiopulmonary diseases), at the discretion of the researchers.
- Severe or uncontrolled infections.
- Active autoimmune disease.
- Clinically significant central nervous system dysfunction.
- Recent major surgery (excluding lymph node biopsy) within the last 30 days.
- Pregnant or breastfeeding women of childbearing age who are not using contraception.
- Drug allergy to study treatments.
- Other reasons, as determined by the researchers, that make the patient unsuitable for participation.
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
Department of Radiation Oncology, Shandong Cancer Hospital and Institute
Jinan, Shandong, 0531
Jinbo Yue, doctor, 0531-67626442, jbyue@sdfmu.edu.cn
About this study
Official title: Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is a primary treatment option; however, postoperative recurrence remains a significant challenge. Postoperative chemotherapy is commonly used as an adjuvant treatment to reduce recurrence risk, but the mechanisms of recurrence, predictive factors, and strategies to enhance chemotherapy efficacy remain unclear.For CRC patients who have achieved No Evidence of Disease (NED), the decision to reinitiate or modify systemic chemotherapy for newly developed pulmonary oligometastases is still debated. Local treatment options for pulmonary oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic therapy should follow local treatment in NED patients is uncertain.This issue is actively debated in multidisciplinary team (MDT) consultations both in our hospital and across the country. Some experts argue that pulmonary oligometastases signify disease progression, requiring systemic treatment, while others suggest that these metastases may not indicate high malignancy and that observation, with possible delayed systemic treatment, could be sufficient.This study will include CRC patients who have achieved NED for at least six months and then develop pulmonary oligometastases, treated exclusively with destructive local therapies (surgery, radiotherapy, or ablation) without systemic therapy. The study will assess the timing of transitioning to the next line of systemic therapy through imaging and ctDNA monitoring.
- Conditions
- Colorectal Neoplasms Malignant
- Being tested
- Oligometastasis Treatment
- Keywords
- Colorectal Neoplasms Malignant, No evidence of disease, Lung metastases, Oligometastasis, Time without systemic therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligometastasis TreatmentCombination product
Oligometastatic Radiotherapy Group: Patients will receive radiotherapy to lung lesions, with the lung metastases outlined as the Gross Tumor Volume (GTV). The prescribed dose will be based on a BED (Biologically Effective Dose) of 72-100 Gy, using either conventional split, macrodissected, or SBRT (Stereotactic Body Radiation Therapy) at the investigator's discretion. No systemic therapy will be administered.
Oligometastatic Radiofrequency Ablation Group: For lesions suitable for radiofrequency ablation, this will be performed in consultation with the Department of Interventional Medicine, considering patient and family preferences. Systemic therapy will not be given.
Oligometastatic Surgery Group: For lesions suitable for surgical resection, patients will undergo surgery after consultation with the Department of Surgery. No systemic therapy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Oligometastasis Treatment | Experimental | including radiotherapy group, radiofrequency ablation group and surgery group Receives: Combination Product: Oligometastasis Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Without Systemic Therapy
The time interval between diagnosis or the completion of the current systemic treatment and the start of the next systemic therapy
Measured: 2 years
Secondary outcomes (8)
Progression-Free Survival（PFS）
The time interval between enrollment and disease progression or death for patients in the intent-to-treat population, whichever occurred first. For those who did not progress at the time of withdrawal from the trial or whose time to disease progression was not recorded, the date of the last examination was used as the endpoint date
Measured: 2 years
Time to Next Treatment (TTNT)
The time interval from the completion of the first SBRT/radiofrequency ablation/surgery to the initiation of the next anticancer treatment or death from any cause
Measured: 2 years
Overall Response Rate (ORR)
Percentage of subjects in the protocol-eligible population and in the intent-to-treat population who achieved CR+PR after treatment
Measured: 2 years
Disease Control Rate (DCR)
Percentage of subjects in the protocol-eligible population and in the intention-to-treat population who achieved CR+PR+SD after treatment
Measured: 2 years
Complete Response Rate (CRR)
Percentage of subjects achieving CR after treatment in the protocol-eligible population as well as in the intent-to-treat population
Measured: 2 years
Duration of Response (DOR)
The time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause
Measured: 2 years
Overall Survival (OS)
The time interval between enrollment and death for patients in the intent-to-treat (ITT) population. If the patient continues to be alive or his/her fate is unknown, the date of death will be the most recent point in time at which the patient was known to be alive
Measured: 2 years
Incidence of Adverse Effects
Evaluation of toxicity according to NCI CTCAE 5.0 criteria
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start24 Jun 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms MalignantStudies of the same condition, open and under way.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinbo Yue, Shandong Cancer Hospital and Institute
- Investigators
- Jinbo Yue, Dorcter, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778382
- Sponsor's protocol ID
- SDZLEC2024-415-01
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horie T, Kanemitsu Y, Takamizawa Y, Moritani K, Tsukamoto S, Shida D. Prognostic differences between oligometastatic and polymetastatic disease after resection in patients with colorectal cancer and hepatic or lung metastases: Retrospective analysis of a large cohort at a single institution. Surgery. 2023 Feb;173(2):328-334. doi: 10.1016/j.surg.2022.10.014. Epub 2022 Nov 15.
PubMed 36400583Benson AB, Venook AP, Adam M, Chang G, Chen YJ, Ciombor KK, Cohen SA, Cooper HS, Deming D, Garrido-Laguna I, Grem JL, Haste P, Hecht JR, Hoffe S, Hunt S, Hussan H, Johung KL, Joseph N, Kirilcuk N, Krishnamurthi S, Malla M, Maratt JK, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Nurkin S, Overman MJ, Parikh A, Patel H, Pedersen K, Saltz L, Schneider C, Shibata D, Shogan B, Skibber JM, Sofocleous CT, Tavakkoli A, Willett CG, Wu C, Gurski LA, Snedeker J, Jones F. Colon Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jun;22(2 D):e240029. doi: 10.6004/jnccn.2024.0029.
PubMed 38862008Loft M, To YH, Gibbs P, Tie J. Clinical application of circulating tumour DNA in colorectal cancer. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):837-852. doi: 10.1016/S2468-1253(23)00146-2. Epub 2023 Jul 24.
PubMed 37499673Wang K, Wang X, Pan Q, Zhao B. Liquid biopsy techniques and pancreatic cancer: diagnosis, monitoring, and evaluation. Mol Cancer. 2023 Oct 6;22(1):167. doi: 10.1186/s12943-023-01870-3.
PubMed 37803304Abbosh C, Hodgson D, Doherty GJ, Gale D, Black JRM, Horn L, Reis-Filho JS, Swanton C. Implementing circulating tumor DNA as a prognostic biomarker in resectable non-small cell lung cancer. Trends Cancer. 2024 Jul;10(7):643-654. doi: 10.1016/j.trecan.2024.04.004. Epub 2024 Jun 4.
PubMed 38839544Tao XY, Li QQ, Zeng Y. Clinical application of liquid biopsy in colorectal cancer: detection, prediction, and treatment monitoring. Mol Cancer. 2024 Jul 16;23(1):145. doi: 10.1186/s12943-024-02063-2.
PubMed 39014366Gouda MA, Janku F, Wahida A, Buschhorn L, Schneeweiss A, Abdel Karim N, De Miguel Perez D, Del Re M, Russo A, Curigliano G, Rolfo C, Subbiah V. Liquid Biopsy Response Evaluation Criteria in Solid Tumors (LB-RECIST). Ann Oncol. 2024 Mar;35(3):267-275. doi: 10.1016/j.annonc.2023.12.007. Epub 2023 Dec 23.
PubMed 38145866
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferred Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After NED in Colorectal Cancer： A Phase II, Single-Arm Clinical Trail.
- ClinicalTrials.gov ID
- NCT06778382
- Acronym / sponsor ID
- SDZLEC2024-415-01
- Conditions
- Colorectal Neoplasms Malignant
- Keywords
- Colorectal Neoplasms Malignant, No evidence of disease, Lung metastases, Oligometastasis, Time without systemic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Jan 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.
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is one of the primary treatment options for CRC; however, postoperative recurrence remains a significant clinical challenge for both the medical community and patients. Postoperative chemotherapy, as an important adjuvant therapy, is widely used in CRC patients aiming to reduce the risk of recurrence. Despite extensive research on the efficacy of postoperative chemotherapy in CRC, the mechanisms of postoperative recurrence, predictive factors, and strategies to enhance chemotherapy effectiveness remain unclear. For colorectal cancer patients who have achieved NED (No Evidence of Disease), the decision to either reinitiate or change the systemic chemotherapy regimen for newly developed pulmonary oligometastases remains controversial. Local treatment options for diagnosing oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic treatment should be added after local treatment in patients who have achieved NED remains uncertain , and this issue requires urgent resolution.
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide. Surgical resection is a primary treatment option; however, postoperative recurrence remains a significant challenge. Postoperative chemotherapy is commonly used as an adjuvant treatment to reduce recurrence risk, but the mechanisms of recurrence, predictive factors, and strategies to enhance chemotherapy efficacy remain unclear.For CRC patients who have achieved No Evidence of Disease (NED), the decision to reinitiate or modify systemic chemotherapy for newly developed pulmonary oligometastases is still debated. Local treatment options for pulmonary oligometastases include surgery, radiotherapy, and radiofrequency ablation. However, whether systemic therapy should follow local treatment in NED patients is uncertain.This issue is actively debated in multidisciplinary team (MDT) consultations both in our hospital and across the country. Some experts argue that pulmonary oligometastases signify disease progression, requiring systemic treatment, while others suggest that these metastases may not indicate high malignancy and that observation, with possible delayed systemic treatment, could be sufficient.This study will include CRC patients who have achieved NED for at least six months and then develop pulmonary oligometastases, treated exclusively with destructive local therapies (surgery, radiotherapy, or ablation) without systemic therapy. The study will assess the timing of transitioning to the next line of systemic therapy through imaging and ctDNA monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oligometastasis Treatment | Experimental | Combination Product: Oligometastasis Treatmentincluding radiotherapy group, radiofrequency ablation group and surgery group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with a pathologically confirmed diagnosis of colorectal cancer with the following disease conditions:
- RECIST 1.1 criteria: The patient must have measurable lesions, defined as at least one nodal lesion with a longest diameter > 1.5 cm, or at least one nodal lesion > 1 cm with an accurately measurable pendulous diameter.
- ECOG performance status: ≤ 2 (Eastern Cooperative Oncology Group general condition score).
- The patient's expected survival must be ≥ 3 months.
- Adequate hematologic function: Absolute neutrophil count ≥ 1.6 x 10⁹/L, with no growth factor support for at least 7 days prior to testing.
Key exclusion criteria (14 listed)
- First diagnosis of advanced colorectal cancer with metastatic disease.
- Multiple lung metastases (> 5 lesions), liver metastasis, bone metastasis, or lymph node metastasis.
- Lung metastases that are not amenable to radiotherapy, as determined by the investigator.
- Previously received second-line or higher systemic treatment.
- Liver or kidney dysfunction: Alanine aminotransferase (ALT) > 3 times the upper limit of normal; Aspartate aminotransferase (AST) > 3 times the upper limit of normal; Total bilirubin (TBIL) > 2 times the upper limit of normal; Serum creatinine > 1.5 times the upper limit of normal.
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 |
|---|---|---|
| Oligometastasis TreatmentOligometastatic Radiotherapy Group: Patients will receive radiotherapy to lung lesions, with the lung metastases outlined as the Gross Tumor Volume (GTV). The prescribed dose will be based on a BED (Biologically Effective Dose) of 72-100 Gy, using either conventional split, macrodissected, or SBRT (Stereotactic Body Radiation Therapy) at the investigator's discretion. No systemic therapy will be administered. Oligometastatic Radiofrequency Ablation Group: For lesions suitable for radiofrequency ablation, this will be performed in consultation with the Department of Interventional Medicine, considering patient and family preferences. Systemic therapy will not be given. Oligometastatic Surgery Group: For lesions suitable for surgical resection, patients will undergo surgery after consultation with the Department of Surgery. No systemic therapy will be performed. | Combination product | Oligometastasis Treatment |
Primary outcome
Time Without Systemic Therapy
Time frame: 2 years
The time interval between diagnosis or the completion of the current systemic treatment and the start of the next systemic therapy
8 secondary outcomes
Progression-Free Survival（PFS）
Time frame: 2 years
Time to Next Treatment (TTNT)
Time frame: 2 years
Overall Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Complete Response Rate (CRR)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Incidence of Adverse Effects
Time frame: 2 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 13 Oct 2026.
- Background: PubMed 36400583Horie T, Kanemitsu Y, Takamizawa Y, Moritani K, Tsukamoto S, Shida D. Prognostic differences between oligometastatic and polymetastatic disease after resection in patients with colorectal cancer and hepatic or lung metastases: Retrospective analysis of a large cohort at a single institution. Surgery. 2023 Feb;173(2):328-334. doi: 10.1016/j.surg.2022.10.014. Epub 2022 Nov 15.
- Background: PubMed 38862008Benson AB, Venook AP, Adam M, Chang G, Chen YJ, Ciombor KK, Cohen SA, Cooper HS, Deming D, Garrido-Laguna I, Grem JL, Haste P, Hecht JR, Hoffe S, Hunt S, Hussan H, Johung KL, Joseph N, Kirilcuk N, Krishnamurthi S, Malla M, Maratt JK, Messersmith WA, Meyerhardt J, Miller ED, Mulcahy MF, Nurkin S, Overman MJ, Parikh A, Patel H, Pedersen K, Saltz L, Schneider C, Shibata D, Shogan B, Skibber JM, Sofocleous CT, Tavakkoli A, Willett CG, Wu C, Gurski LA, Snedeker J, Jones F. Colon Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jun;22(2 D):e240029. doi: 10.6004/jnccn.2024.0029.
- Background: PubMed 37499673Loft M, To YH, Gibbs P, Tie J. Clinical application of circulating tumour DNA in colorectal cancer. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):837-852. doi: 10.1016/S2468-1253(23)00146-2. Epub 2023 Jul 24.
- Background: PubMed 37803304Wang K, Wang X, Pan Q, Zhao B. Liquid biopsy techniques and pancreatic cancer: diagnosis, monitoring, and evaluation. Mol Cancer. 2023 Oct 6;22(1):167. doi: 10.1186/s12943-023-01870-3.
- Background: PubMed 38839544Abbosh C, Hodgson D, Doherty GJ, Gale D, Black JRM, Horn L, Reis-Filho JS, Swanton C. Implementing circulating tumor DNA as a prognostic biomarker in resectable non-small cell lung cancer. Trends Cancer. 2024 Jul;10(7):643-654. doi: 10.1016/j.trecan.2024.04.004. Epub 2024 Jun 4.
- Background: PubMed 39014366Tao XY, Li QQ, Zeng Y. Clinical application of liquid biopsy in colorectal cancer: detection, prediction, and treatment monitoring. Mol Cancer. 2024 Jul 16;23(1):145. doi: 10.1186/s12943-024-02063-2.
- Background: PubMed 38145866Gouda MA, Janku F, Wahida A, Buschhorn L, Schneeweiss A, Abdel Karim N, De Miguel Perez D, Del Re M, Russo A, Curigliano G, Rolfo C, Subbiah V. Liquid Biopsy Response Evaluation Criteria in Solid Tumors (LB-RECIST). Ann Oncol. 2024 Mar;35(3):267-275. doi: 10.1016/j.annonc.2023.12.007. Epub 2023 Dec 23.
- 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.
Jinbo Yue, Dorcter principal investigator
Shandong Cancer Hospital and Institute
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 Oligometastasis Treatment in people with Colorectal Neoplasms Malignant, run by Shandong Cancer Hospital and Institute 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 13 inclusion and 14 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 13 Oct 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 Jinbo Yue, Dorcter (0531-67626442, jbyue@sdfmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Without Systemic Therapy (time frame: 2 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 NCT06778382, which also lists 7 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 13 Oct 2026.