Locally Advanced Resectable Rectal CancerPhase 2/3NCT07454720
A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer
A Phase 2/3 study testing Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy and Chemotherapy in people with Locally Advanced Resectable Rectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Resectable Rectal Cancer
- What is being tested?
- Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesChina
- Study dates
- 23 Mar 2026to Nov 2035
- Phase
- Phase 2/3
- 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.
- An assessment of resectable locally advanced rectal.
- Has not received any anti-tumor treatment for rectal cancer.
- With a life expectancy of ≥2 years.
- Male participants whose partners are fertile women and fertile female participants must take effective contraceptive measures together with their partners from the time of signing the informed consent form until 6 months after the last administration of the investigational drug or the last radiotherapy. Female participants with fertility must have a negative serum or urine test for human chorionic gonadotropin (HCG) within 7 days before the first administration of the drug (if the serum HCG test is positive, pregnancy should be ruled out and further discussion with the sponsor should be conducted), and they must be not in the lactation period.
Who cannot join
- Patients with rectal cancer who have experienced local recurrence after previous treatment.
- Patients with concurrent colon tumors.
- Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
- Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding.
- With distant metastases.
- Imaging examination of rectal cancer indicated positive lateral lymph nodes.
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- Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors.
- Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period.
- There are uncontrollable mental illnesses and other circumstances known to affect the completion of the research procedures, such as alcohol abuse, drug abuse or drug 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Ji Zhu, +86-13606711766, zhuji@zjcc.org.cn
Ji Zhu
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tao Zhang, +86-18971656660, xhzlzxzt@163.com
Kaixiong Tao, +86-13507155452, tao_kaixiong@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab Combined With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Resectable Rectal Cancer
The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.
- Being tested
- Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab in combination with SHR-8068 and chemotherapyDrug
Adebrelimab in combination with SHR-8068 and chemotherapy.
Adebrelimab combined with chemotherapyDrug
Adebrelimab combined with chemotherapy.
ChemotherapyDrug
Chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients will receive radiotherapy and Adebrelimab in combination with SHR-8068 and chemotherapy as perioperative treatment. Receives: Drug: Adebrelimab in combination with SHR-8068 and chemotherapy |
| Cohort 2 | Experimental | Patients will receive radiotherapy and Adebrelimab combined with chemotherapy as perioperative treatment. Receives: Drug: Adebrelimab combined with chemotherapy |
| Cohort 3 | Experimental | Patients will receive radiotherapy plus chemotherapy as perioperative treatment. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: pCR (Pathological Complete Response) rate
Evaluated by investigators.
Measured: 12 months
Secondary outcomes (8)
Phase II: Clinical complete response (cCR) rate
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: Disease-free survival (DFS)
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: EFS (Event Free Survival)
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: Tumor regression grade (TRG)
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: R0 resection rate
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: length of hospital stay
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: Overall survival (OS)
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Phase II: Perioperative mortality (within 30 days and 90 days after surgery)
Evaluated by investigators per RECIST v1.1.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start23 Mar 2026
- Primary completionNov 2032 (estimated)
- Study completionNov 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Resectable Rectal 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
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
- NCT07454720
- Sponsor's protocol ID
- SHR-1316-308
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Clinical Study of Adebrelimab Combined With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Resectable Rectal Cancer
- ClinicalTrials.gov ID
- NCT07454720
- Acronym / sponsor ID
- SHR-1316-308
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2035 (estimated)
- First posted
- 6 Mar 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.
The study is being conducted to evaluate the safety and efficacy of Adebrelimab and SHR-8068 in combination with chemoradiotherapy in subjects with rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Adebrelimab in combination with SHR-8068 and chemotherapyPatients will receive radiotherapy and Adebrelimab in combination with SHR-8068 and chemotherapy as perioperative treatment. |
| Cohort 2 | Experimental | Drug: Adebrelimab combined with chemotherapyPatients will receive radiotherapy and Adebrelimab combined with chemotherapy as perioperative treatment. |
| Cohort 3 | Experimental | Drug: ChemotherapyPatients will receive radiotherapy plus chemotherapy as perioperative treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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.
- An assessment of resectable locally advanced rectal.
- Has not received any anti-tumor treatment for rectal cancer.
Key exclusion criteria (10 listed)
- Patients with rectal cancer who have experienced local recurrence after previous treatment.
- Patients with concurrent colon tumors.
- Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
- Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding.
- With distant metastases.
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 |
|---|---|---|
| Adebrelimab in combination with SHR-8068 and chemotherapyAdebrelimab in combination with SHR-8068 and chemotherapy. | Drug | Cohort 1 |
| Adebrelimab combined with chemotherapyAdebrelimab combined with chemotherapy. | Drug | Cohort 2 |
| ChemotherapyChemotherapy. | Drug | Cohort 3 |
Primary outcome
Phase II: pCR (Pathological Complete Response) rate
Time frame: 12 months
Evaluated by investigators.
8 secondary outcomes
Phase II: Clinical complete response (cCR) rate
Time frame: 60 months
Phase II: Disease-free survival (DFS)
Time frame: 60 months
Phase II: EFS (Event Free Survival)
Time frame: 60 months
Phase II: Tumor regression grade (TRG)
Time frame: 60 months
Phase II: R0 resection rate
Time frame: 60 months
Phase II: length of hospital stay
Time frame: 60 months
Phase II: Overall survival (OS)
Time frame: 60 months
Phase II: Perioperative mortality (within 30 days and 90 days after surgery)
Time frame: 60 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 5 May 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy and Chemotherapy in people with Locally Advanced Resectable Rectal Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 7 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 5 May 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chuanpei Huang (+86-021-61053363, chuanpei.huang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: pCR (Pathological Complete Response) rate (time frame: 12 months). 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 5 May 2026.