Colorectal CancerPhase 2NCT07071714
A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
A Phase 2 study testing SHR-8068 Injection, Adebrelimab Injection and Bevacizumab Injection in people with Colorectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SHR-8068 Injection, Adebrelimab Injection and Bevacizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2025to Oct 2031
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
About this study
Official title: An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
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.
- Conditions
- Colorectal Cancer
- Being tested
- SHR-8068 Injection, Adebrelimab Injection, Bevacizumab Injection
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068 InjectionDrug
SHR-8068 injection.
Adebrelimab InjectionDrug
Adebrelimab injection.
Bevacizumab InjectionDrug
Bevacizumab injection.
| Study group | Role | What they receive |
|---|---|---|
| Part A Group | Experimental | Not described Receives: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection |
| Part B Group | Experimental | Not described Receives: Drug: SHR-8068 Injection; Drug: Adebrelimab Injection; Drug: Bevacizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Measured: About 7 months.
Progression Free Survival (PFS)
Measured: About 18 months.
Secondary outcomes (8)
Clinical Complete Response (cCR)
Measured: About 60 months.
Disease Free Survival (DFS)
Measured: About 60 months.
Event Free Survival (EFS）
Measured: About 60 months.
Overall Survival (OS)
Measured: About 60 months.
Duration of Response (DoR)
Measured: About 18 months.
Overall Response Rate (ORR)
Measured: About 18 months.
Disease Control Rate (DCR)
Measured: About 18 months.
Adverse Events (AEs)
Measured: Up to about 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start22 Jul 2025
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071714
- Sponsor's protocol ID
- SHR-8068-206
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07071714
- Acronym / sponsor ID
- SHR-8068-206
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 17 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A Group | Experimental | Drug: SHR-8068 Injection, Drug: Adebrelimab Injection |
| Part B Group | Experimental | Drug: SHR-8068 Injection, Drug: Adebrelimab Injection, Drug: Bevacizumab Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| SHR-8068 InjectionSHR-8068 injection. | Drug | Part A Group, Part B Group |
| Adebrelimab InjectionAdebrelimab injection. | Drug | Part A Group, Part B Group |
| Bevacizumab InjectionBevacizumab injection. | Drug | Part B Group |
Primary outcome
Pathological Complete Response (pCR)
Time frame: About 7 months.
Progression Free Survival (PFS)
Time frame: About 18 months.
8 secondary outcomes
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.
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR-8068 Injection, Adebrelimab Injection and Bevacizumab Injection in people with Colorectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: About 7 months.). The study lists 2 primary outcomes in all. 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 11 Aug 2026.