Metastatic Colorectal CancerPhase 2NCT07718490
Immunotheray Combined With Simvastatin and Target Therapy and Chemotharepy for Advanced Colorectal Cancer
A Phase 2 study testing Adebrelimab in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Adebrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2025to 31 Mar 2028
- 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
- Able to provide written informed consent and voluntarily participate in this study.
- Male or female subjects aged between 18 and 75 years, inclusive.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- No prior systemic anti-tumor therapy; patients who have received neoadjuvant/adjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of at least 3 months.
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- Presence of at least one measurable lesion at baseline assessed by the investigator according to RECIST 1.1. Measurable lesions must not have been previously treated with radiotherapy or other local therapy, unless the lesion located in a previously irradiated area has been confirmed to have progressed.
- Adequate organ function as defined below (no blood products or hematopoietic growth factors are allowed within 14 days prior to the first dose of study treatment):
- Absolute neutrophil count (ANC) ≥1.5×10^9/L
- Platelet count ≥100×10^9/L
- Hemoglobin ≥9 g/dL
- Serum albumin ≥2.5 g/dL
- Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in the presence of liver metastases
- Serum creatinine ≤1.5 × ULN, or creatinine clearance >60 mL/min (calculated by Cockcroft-Gault formula)
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5 × ULN. Subjects receiving stable-dose anticoagulation such as low molecular weight heparin or warfarin with INR within the expected therapeutic range are eligible.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment, must not be breastfeeding, and must agree to use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for at least 6 months after the last dose of study treatment. Male subjects with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 3 months after the last dose of study treatment, and must not donate sperm during the study period.
Who cannot join
- Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability.
- Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug.
- History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- Subjects with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular or ventricular arrhythmias without clinical intervention or still poorly controlled after clinical intervention.
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- Significant clinically relevant bleeding symptoms or clear bleeding tendency within 3 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis.
- Arterial/venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism. Superficial venous thrombosis may be included at the investigator's discretion.
- Presence of another progressing or actively treated malignancy, except for non-melanoma skin cancer and cervical carcinoma in situ that have received curative treatment.
- Subjects with other factors that, in the investigator's opinion, may lead to premature discontinuation of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, clinically significant laboratory abnormalities, family or social factors that may affect subject safety or trial data collection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, 210008
Yanhong Gu, +86 25 6830 6714, guyanhong@njmu.edu.cn
- Not yet recruiting
Nanjing First Hospital, Nanjing Medical University Affiliated Hospital
Nanjing, Jiangsu
Xiaowei Wei, +8613813973094, gswxw@126.com
About this study
Official title: A Multicenter, Prospective, Phase II Exploratory Study on the First-line Treatment of MSS/ PMMR-type Advanced Colorectal Cancer With Adebrelimab Combined With Simvastatin and Targeted and Chemotherapy
Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H/dMMR is present in only 15%-20% of stage II/III and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR/MSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Adebrelimab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab[1200mg i.v, q3w], Capecitabine [1000mg/m² po, bid, d1-d14, q3w], Oxaliplatin [130mg/m² i.v, d1, q3w], Bevacizumab [7.5mg/kg i.v, d1, q3w], Simvastatin [80mg po qd] regimen treatment, 6-8 weeks, then enter the maintenance phase, with oxaliplatin discontinued during the maintenance phase
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab + Chemotherapy + Targeted Therapy + Simvastatin | Experimental | Not described Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Objective Response Rate（ORR）
ORR is the proportion of participants with investigator-assessed complete or partial response per [RECIST 1.1] criteria, with response confirmed on subsequent imaging.
Measured: 2 years.
Secondary outcomes (4)
Overall Survival(OS)
OS is the time from treatment initiation to death from any cause. Patients alive at study end will be censored at their last known contact date.
Measured: up to 5 years after treatment discontinuation
Progression Free Survival(PFS)
PFS is the time from treatment initiation to disease progression or death (whichever comes first), assessed per [RECIST 1.1] criteria. Patients without events at study end will be censored at their last assessment date.
Measured: From treatment initiation until documented disease progression, death, or up to 1 years of follow-up, with survival follow-up conducted every 3 months (±14 days) via telephone after treatment discontinuation.
Disease Control Rate(DCR)
DCR is the proportion of participants with investigator-assessed CR, PR, or SD per [RECIST 1.1] criteria, with response confirmed on subsequent imaging.
Measured: Imaging examinations will be performed every 6 weeks for the first 12 months after initial treatment, then every 12 weeks thereafter through study completion (maximum follow-up of 1 years).
Safety (Adverse Events, Vital Signs, Laboratory Parameters, and Quality of Life Assessed Using NCI-CTCAE v5.0)
Measured: From ICF through 100 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718490
- Sponsor's protocol ID
- 2025-SR-692.A2
- Status last verified
- Aug 2025
- First submitted
- 10 May 2026
- Last updated
- 22 Jul 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase II Exploratory Study on the First-line Treatment of MSS/ PMMR-type Advanced Colorectal Cancer With Adebrelimab Combined With Simvastatin and Targeted and Chemotherapy
- ClinicalTrials.gov ID
- NCT07718490
- Acronym / sponsor ID
- 2025-SR-692.A2
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Jul 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.
Metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) molecular phenotypes could significantly benefit from immune checkpoint inhibitor therapy, ushering in the MSI era of immunotherapy for colorectal cancer. However, MSI-H/dMMR is present in only 15%-20% of stage II/III and 5% of stage IV colorectal cancer patients, while the vast majority of patients exhibit microsatellite stability (MSS) or proficient mismatch repair (pMMR) types, which are insensitive to immunotherapy. Therefore, how to enhance the efficacy of immunotherapy in the pMMR/MSS population through combination therapy has become a hotspot and challenge in colorectal cancer research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab + Chemotherapy + Targeted Therapy + Simvastatin | Experimental | Drug: Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Able to provide written informed consent and voluntarily participate in this study.
- Male or female subjects aged between 18 and 75 years, inclusive.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- No prior systemic anti-tumor therapy; patients who have received neoadjuvant/adjuvant therapy are eligible if the time from the last chemotherapy to recurrence or progression is more than 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (10 listed)
- Received local radiotherapy within 4 weeks prior to the first dose of study drug, and adverse events due to radiotherapy have not recovered to baseline levels. Subjects who received palliative radiotherapy to peripheral sites (e.g., bone metastases) more than 4 weeks prior to the first dose are eligible, provided they have recovered from any acute adverse reactions.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they have stable brain metastases and have not required steroid treatment for brain metastases for at least 28 days prior to study entry. This exception does not apply to carcinomatous meningitis, which is excluded regardless of clinical stability.
- Major surgery, open biopsy, or severe trauma within 28 days prior to the first dose of study drug.
- History of allergy to any anti-angiogenic agents, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
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 |
|---|---|---|
| AdebrelimabAdebrelimab[1200mg i.v, q3w], Capecitabine [1000mg/m² po, bid, d1-d14, q3w], Oxaliplatin [130mg/m² i.v, d1, q3w], Bevacizumab [7.5mg/kg i.v, d1, q3w], Simvastatin [80mg po qd] regimen treatment, 6-8 weeks, then enter the maintenance phase, with oxaliplatin discontinued during the maintenance phase | Drug | Adebrelimab + Chemotherapy + Targeted Therapy + Simvastatin |
Primary outcome
Investigator-assessed Objective Response Rate（ORR）
Time frame: 2 years.
ORR is the proportion of participants with investigator-assessed complete or partial response per [RECIST 1.1] criteria, with response confirmed on subsequent imaging.
4 secondary outcomes
Overall Survival(OS)
Time frame: up to 5 years after treatment discontinuation
Progression Free Survival(PFS)
Time frame: From treatment initiation until documented disease progression, death, or up to 1 years of follow-up, with survival follow-up conducted every 3 months (±14 days) via telephone after treatment discontinuation.
Disease Control Rate(DCR)
Time frame: Imaging examinations will be performed every 6 weeks for the first 12 months after initial treatment, then every 12 weeks thereafter through study completion (maximum follow-up of 1 years).
Safety (Adverse Events, Vital Signs, Laboratory Parameters, and Quality of Life Assessed Using NCI-CTCAE v5.0)
Time frame: From ICF through 100 days after the last dose of study treatment
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 22 Jul 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab in people with Metastatic Colorectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites 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 10 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yanhong Gu (+86 25 6830 6714, guyanhong@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Objective Response Rate（ORR） (time frame: 2 years.). 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 22 Jul 2026.