- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06304545
Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab
Long-course Concurrent Chemoradiotherapy Combined With Camrelizumab in the Neoadjuvant Treatment of Locally Advanced/Low Anus-preserving Rectal Cancer: a Phase II Single-arm Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chunbo Zhao, MD
- Phone Number: +86-13644640662
- Email: chunbozhao@hrbmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: 18 to 75 years old, male or female,
- Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria),
- Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (<5 cm from anal verge; T2N0M0),
- Expected survival > 3 months,
- ECOG PS score: 0-1,
- No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed,
- No previous radiotherapy or immune checkpoint inhibitor treatment for rectal cancer,
- Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during screening):
1)Absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 80 x 10^9/L; hemoglobin ≥ 8.5 g/dL, 2)Thyroid-stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled), 3)Bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN, 4) Serum creatinine ≤1.5 times ULN, 9. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose, 10. Subjects voluntarily enrolled in the study and signed an informed consent form.
Exclusion Criteria:
- Previous pelvic or abdominal radiotherapy,
- Tumours that are expected to be unresectable after neoadjuvant therapy,
- Pregnant or lactating women, or those of childbearing potential who refuse to use contraception,
- History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled,
- Ineffectively controlled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction,
- Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function,
- Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment,
- Congestive heart failure, difficult-to-control cardiac arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient is chaemic attack, severe hypertension difficult to control with medication, or other patients who cannot tolerate the procedure,
- Severe active infections requiring intravenous antibiotic treatment occurring during the screening period,
- Allergy to the test drug,
- Have received or will receive a live vaccine within 30 days prior to camrelizumab administration,
- Known history of HIV infection or active hepatitis B or C,
- Patients who are unable to comply with the trial protocol or are unable to cooperate with follow-up visits,
- Those who in the opinion of the investigator are not suitable for participation in this trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemoradiotherapy combined with immunotherapy for early rectal cancer.
Radiotherapy and Chemotherapy combined with Camrelizumab
|
Camrelizumab IV 200mg
Other Names:
Capecitabine PO oxaliplatin IV
Other Names:
Radiotherapy 50Gy /45Gy /25 fractions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Complete Response rate
Time Frame: up to 24 months
|
After neoadjuvant therapy and surgery, postoperative specimens showed no residual surviving tumor cells in the tumor bed (%RVT=0).
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: up to 24 months
|
Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
|
up to 24 months
|
AEs
Time Frame: up to 24 months
|
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
|
up to 24 months
|
Disease Control Rate
Time Frame: up to 24 months
|
Determined using RECIST v1.1 criteria.
|
up to 24 months
|
Anal preservation rate
Time Frame: up to 24 months
|
Proportion of patients with low rectal cancer who retain their anus after surgery.
|
up to 24 months
|
Disease-free Survival
Time Frame: up to 24 months
|
The time from surgical resection to the first tumor recurrence and metastasis, or the patient's death due to any reason.
|
up to 24 months
|
Overall Survival
Time Frame: up to 36 months
|
Defined as the time from randomizstion to death from any cause.
|
up to 36 months
|
3-years Overall Survival rate
Time Frame: up to 36 months
|
Proportion of death from randomization to 3 years of treatment.
|
up to 36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chunbo Zhao, MD, Harbin Medical University Cancer Hosptital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- SHR-1210-HLJ-081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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