Recruiting NCT07454720
A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adebrelimab in combination with SHR-8068 and chemotherapy, Adebrelimab combined with chemotherapy, Chemotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Resectable Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Adebrelimab in combination with SHR-8068 and chemotherapy
Adebrelimab in combination with SHR-8068 and chemotherapy. - Drug Adebrelimab combined with chemotherapy
Adebrelimab combined with chemotherapy. - Drug Chemotherapy
Chemotherapy.
Primary outcome measures
- Phase II: pCR (Pathological Complete Response) rate [Time frame: 12 months]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Te — Wuhan
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07454720 · SHR-1316-308