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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: chuanpei.huang@hengrui.com
• Phone: +86-021-61053363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Propranolol with Adebrelimab and Platinum Chemotherapy in Small Cell Lung Cancer

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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• Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

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  Recruiting Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Jinan, Shandong · NCT07798947

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

  This study tests whether adding adebrelimab to a regimen of apatinib and albumin-bound paclitaxel helps patients with advanced gastric or gastroesophageal junction cancer who did not respond to first-line therapy.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

  This trial tests a short course of radiotherapy combined with Adebrelimab and platinum chemotherapy to shrink locally advanced cervical cancer before surgery.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07731828

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.