Virus-Immunotherapy combo targets Hard-to-Treat colorectal cancer
NCT ID NCT07411781
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a combination of a specially modified virus (PIN) and an immunotherapy drug (sintilimab) in about 25 adults with advanced colorectal cancer that has spread to the liver and has not responded to at least two prior treatments. The main goals are to check the safety of the combination and see if it can shrink tumors. Participants must be between 18 and 75 years old and have a specific type of colorectal cancer called pMMR/MSS.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 (inclusive). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Estimated life expectancy of more than 3 months. 3. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic CRC with hepatic metastases have failed at least two lines of prior treatment. 4. Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or MSS by polymerase chain reaction (PCR). 5. At least one measurable lesion at baseline according to investigators Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1). 6. Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging) in the liver metastatic lesions, defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, lymph node or visceral organ with a longest diameter ≥10 mm. 7. Subjects are willing to accept tumor rebiopsy in the process of this study. 8. Adequate organ function as defined by the following criteria: * Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L, Platelet count ≥50 x 10\^9/ L, hemoglobin (Hgb) ≥ 80g/L ; * Serum creatinine≤1.5 upper limit of normal (ULN) or creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min; * Serum aspartate amino transferase (AST) and alanine aminotransferase (ALT), ≤5 x ULN ; Total serum bilirubin ≤3 x ULN); * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings; * International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN; * Baseline oxygen saturation \>91% on room air. 9. Previous treatments must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to \<= grade 1 toxicity (except for hematological toxicities and clinically non-significant toxicities such as alopecia). 10. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year. 11. Voluntarily participate in this clinical trial and sign an informed consent form. Exclusion Criteria: 1. Participants with DNA mismatch repair-deficient or microsatellite instability-high (dMMR /MSI-H) CRC. 2. Advanced CRC without hepatic metastases. 3. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. 4. Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 drug-related Central Nervous System (CNS) toxicity. 5. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. 6. Any serious underlying medical (eg, pulmonary, renal, hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements. 7. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered. 8. Received cytotoxic chemicals, monoclonal antibodies, immunotherapy or other intervene within 4 weeks or 5 half-lives before enrollment. 9. Received radiotherapy within 3 months before enrollment. 10. Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy. 11. The presence of uncontrollable serous membrane fluid, such as massive pleural effusion or ascites. 12. Previous or concurrent cancer within 3 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)\]. 13. Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). 14. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation. 15. History of allergy or intolerance to study drug components. 16. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented. 17. Being participating any other trials or withdraw within 4 weeks. 18. Researchers believe that other reasons are not suitable for clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
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