Actively Recruiting
A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-01-20
15
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
B
Beijing Geekgene Technology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
CONDITIONS
Official Title
A Single-arm, Open-label Study of GK01 in Combination With or Without Chemotherapy for the Adjuvant Treatment of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document.
- Age between 18 and 70 years at the time of consent, male or female.
- Histopathologically confirmed solid tumors, including but not limited to pancreatic cancer, cholangiocarcinoma, gastric cancer.
- Suitable for radical total resection of the primary tumor aimed at cure.
- No prior treatment for the primary tumor before surgery (no induction therapy or recurrent disease).
- Expected survival time longer than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You will not qualify if you...
- Inoperable or metastatic (Stage IV) solid tumors.
- Central nervous system metastasis, leptomeningeal disease, metastatic spinal cord compression, or history of CNS disorders such as epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease.
- History of bone marrow or solid organ transplantation.
- Other primary malignancies within 5 years before study treatment.
- Positive for hepatitis B surface antigen; or negative for HBsAg but positive for hepatitis B core antibody with positive hepatitis B virus DNA; positive hepatitis C antibody and RNA; positive HIV antibody; positive cytomegalovirus DNA; positive for both Treponema pallidum-specific and non-specific antibodies.
- Allergy to study drug components.
- Radiotherapy within 28 days before consent.
- Active tuberculosis infection within 1 year before screening.
- Current or past interstitial lung disease or pneumonia; chronic lung disease or other respiratory conditions significantly impairing lung function.
- Active or history of autoimmune disease that may recur or at risk, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis.
- Clinically significant thyroid dysfunction.
- Clinically significant cardiovascular diseases.
- Contraindications to curative resection of the primary tumor.
- Attenuated or inactivated vaccines within 28 days before consent or planned during screening.
- Comorbidities or conditions affecting protocol compliance or participation suitability.
- Female subjects who are pregnant or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jihui Hao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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