A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer

April 29, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Tao Zhang
        • Principal Investigator:
          • Kaixiong Tao
        • Contact:
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Ji Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Patients will receive radiotherapy and Adebrelimab in combination with SHR-8068 and chemotherapy as perioperative treatment.
Drug: Adebrelimab in combination with SHR-8068 and chemotherapy
Adebrelimab in combination with SHR-8068 and chemotherapy.
Experimental: Cohort 2
Patients will receive radiotherapy and Adebrelimab combined with chemotherapy as perioperative treatment.
Drug: Adebrelimab combined with chemotherapy
Adebrelimab combined with chemotherapy.
Experimental: Cohort 3
Patients will receive radiotherapy plus chemotherapy as perioperative treatment.
Drug: Chemotherapy
Chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase II: pCR (Pathological Complete Response) rate
Time Frame: 12 months
Evaluated by investigators.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase II: Clinical complete response (cCR) rate
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: Disease-free survival (DFS)
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: EFS (Event Free Survival)
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: Tumor regression grade (TRG)
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: R0 resection rate
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: length of hospital stay
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: Overall survival (OS)
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months
Phase II: Perioperative mortality (within 30 days and 90 days after surgery)
Time Frame: 60 months
Evaluated by investigators per RECIST v1.1.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2035

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1316-308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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