Recruiting NCT07071714
A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-8068 Injection, Adebrelimab Injection, Bevacizumab Injection.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
Overview
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.
Interventions
- Drug SHR-8068 Injection
SHR-8068 injection. - Drug Adebrelimab Injection
Adebrelimab injection. - Drug Bevacizumab Injection
Bevacizumab injection.
Primary outcome measures
- Pathological Complete Response (pCR) [Time frame: About 7 months.]
- Progression Free Survival (PFS) [Time frame: About 18 months.]
Secondary outcome measures (8)
- Clinical Complete Response (cCR) [Time frame: About 60 months.]
- Disease Free Survival (DFS) [Time frame: About 60 months.]
- Event Free Survival (EFS） [Time frame: About 60 months.]
- Overall Survival (OS) [Time frame: About 60 months.]
- Duration of Response (DoR) [Time frame: About 18 months.]
- Overall Response Rate (ORR) [Time frame: About 18 months.]
- Disease Control Rate (DCR) [Time frame: About 18 months.]
- Adverse Events (AEs) [Time frame: Up to about 18 months.]
Eligibility criteria
Inclusion criteria
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- Male or female ≥ 18 years old and ≤75 years old.
- ECOG performance status of 0-1.
- Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
- Need to provided tumor tissue samples for genetic testing.
Exclusion criteria
- Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
- Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
- Part B: Palliative radiotherapy was completed within 14 days before the first dose.
- Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
- Subjects with known or suspected interstitial pneumonia.
- Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
- Have poorly controlled or severe cardiovascular disease.
- Subjects with active hepatitis B or active hepatitis C.
- A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
- The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
- Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07071714 · SHR-8068-206