Adebrelimab plus SHR-8068 with chemoradiotherapy as perioperative care for resectable locally advanced rectal cancer.

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

This trial will test whether adding two immunotherapy drugs (adebrelimab and SHR-8068) to chemoradiotherapy around the time of surgery helps people with resectable locally advanced rectal cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT07454720 on ClinicalTrials.gov

What this trial studies

This multicenter phase 2/3 interventional study gives participants one of several perioperative regimens that include adebrelimab plus SHR-8068 with chemoradiotherapy, adebrelimab with chemotherapy, or chemotherapy alone, administered around the time of surgery. Participants are enrolled at regional oncology centers in China and are followed for safety, tumor response, surgical outcomes, and longer-term recurrence. Key outcomes likely include rates of tumor downstaging and pathologic complete response as well as adverse events related to the combinations. The trial is sponsored by a biopharmaceutical company and targets patients who have not received prior anti-tumor therapy for their rectal cancer.

Who should consider this trial

Good fit: Adults aged 18–75 with resectable locally advanced rectal cancer, ECOG performance status 0–1, no prior anti-tumor treatment, and adequate life expectancy are the intended participants.

Not a fit: People with unresectable or metastatic disease, prior rectal cancer treatment, poor performance status, or who are pregnant are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could increase tumor response before surgery and lower recurrence risk, potentially allowing better surgical outcomes or less extensive operations.

How similar studies have performed: Early studies combining immunotherapy with chemoradiation in rectal cancer have shown promising signals for increased pathologic complete response, but the specific adebrelimab plus SHR-8068 combination is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. An assessment of resectable locally advanced rectal.
5. Has not received any anti-tumor treatment for rectal cancer.
6. With a life expectancy of ≥2 years.
7. 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.

Exclusion Criteria:

1. Patients with rectal cancer who have experienced local recurrence after previous treatment.
2. Patients with concurrent colon tumors.
3. Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery.
4. 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.
5. With distant metastases.
6. Imaging examination of rectal cancer indicated positive lateral lymph nodes.
7. Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors.
8. Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period.
9. 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.
10. 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.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Chuanpei Huang

Conditions Locally Advanced Resectable Rectal Cancer