- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998122
Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
Total Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal High-Risk or Very High-Risk Patients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wang Quan, Prof.
- Phone Number: +86-431-81875602
- Email: wquan@jlu.edu.cn
Study Contact Backup
- Name: PengYu Chang, Prof.
- Email: changpengyu@mails.jlu.edu.cn
Study Locations
-
-
Ji Lin
-
Changchun, Ji Lin, China
- First Hospital of Jilin University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patients and their families are able to understand and are willing to participate in this clinical study, and sign an informed consent form.
- Age: 18~75 years old, no gender limit;
- Pathologically diagnosed rectal adenocarcinoma: differentiated into Grade 1-3, that is, high, medium, and poorly differentiated tubular adenocarcinoma; classified as pMMR/MSS.
- The initial TNM risk category (from Rectal cancer: ESMO Clinical Practice Guidelines, 2017 edition) is as follows: 1) "Bad": cT3c/d or very low localisation levators threatened, MRF clear; cT3c/d mid-rectum, cN1-N2 (extranodal), EMVI+, limited cT4aN0; 2) "Advanced": cT3 with any MRF involved, any cT4a/b, lateral node+.
- The lower edge of the tumor is located below the peritoneal reflex;
- No distant transfer;
- ECOG PS score 0-1 within 7 days before the first medication;
- Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-). If HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be less than 1000 copies/mL or 200 IU/mL before entering the group.
- HCV antibody (-)
- The main organ function is normal.
- No history of pelvic radiotherapy;
- No history of rectal cancer surgery or chemotherapy;
- Not accompanied by systemic infections requiring antibiotic treatment;
- Heart, lung, liver, and kidney functions can tolerate surgery;
- Others, based on the results of previous medical history, vital signs, physical examination or laboratory examination, the research doctor judges that you are suitable for participating in this clinical study.
Exclusion Criteria:
- Recurrent rectal cancer;
- Patients who are planning to undergo or have previously received organ or bone marrow transplantation;
- Myocardial infarction or poorly controlled arrhythmia (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females) occurred within 6 months before the first medication (QTc interval is calculated by Fridericia formula);
- Existence of NYHA standard grade III to IV cardiac insufficiency or color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) <50%;
- Human immunodeficiency virus (HIV) infection;
- Suffer from active tuberculosis;
- Past and present patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc., which may interfere with the detection and treatment of suspected drug-related lung toxicity;
- Patients with active or suspicious autoimmune disease, or with a history of that;
- Received treatment with live vaccines within 28 days before the first administration; except for inactivated viral vaccines for seasonal influenza;
- Have received other antibody/drug treatments against immune checkpoints in the past, such as PD-1, PD-L1, CTLA4, etc.;
- Known to have a history of severe allergies to any monoclonal antibody or research drug excipients;
- In the past 5 years, patients have suffered from malignant tumors whose survival rate is significantly lower than the historical data of our rectal cancer survival rate (properly treated basal cell carcinoma, skin squamous cell carcinoma, small kidney cancer, breast cancer, and papillary thyroid carcinoma are not included here. range);
- The patient has had arterial embolism diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.;
- Have received other types of anti-tumor or experimental treatments;
- The patient is a female during pregnancy or lactation;
- The patient has other diseases or abnormal mental states, which may affect the patient's participation in this study;
- There are patients who may increase the risk of participating in research and research medication, or other severe, acute and chronic diseases, who are not suitable for clinical research based on the judgment of the investigator.
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: Experimental
Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient. |
Radiation: Long-course chemoradiotherapy is delivered in 50 Gy/25 fractions with concurrent Capecitabine (825mg/m2, P.O. Bid, 5d/w). Drug: CapeOX (Capecitabine 1000mg/m2, P.O. Bid, d1-d14, q3w; Oxaliplatin 130mg/m2, i.v., d1, q3w), and Sintilimab (200mg, i.v. , d1). Surgical Approach: TME surgery, The surgical approach can be open, laparoscopic or robotic depending on the patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response rate (CR)
Time Frame: Within one week after Last treatment
|
defined as clinical complete response (cCR) or pathologic complete response (pCR) achieved after neoadjuvant therapy.
|
Within one week after Last treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wexner score
Time Frame: up to 12 months
|
Wexner incontinence score
|
up to 12 months
|
Disease-Free Survival (DFS)
Time Frame: 1/2/3 years from the date of receiving neoadjuvant therapy
|
1/2/3 years disease-free survival
|
1/2/3 years from the date of receiving neoadjuvant therapy
|
Recurrence -Free Survival (RFS)
Time Frame: 1/2/3 years from the date of receiving neoadjuvant therapy
|
1/2/3 years recurrence -free survival
|
1/2/3 years from the date of receiving neoadjuvant therapy
|
Overall Survival (OS)
Time Frame: 3 years from the date of receiving neoadjuvant therapy
|
3 years overall survival
|
3 years from the date of receiving neoadjuvant therapy
|
Local Recurrence (LR) Rate
Time Frame: 2 years from the date of receiving neoadjuvant therapy
|
2-year local recurrence rate
|
2 years from the date of receiving neoadjuvant therapy
|
Organ preservation rate
Time Frame: 1/2/3 years from the date of receiving neoadjuvant therapy
|
Organ preservation rate
|
1/2/3 years from the date of receiving neoadjuvant therapy
|
R0 Resection rate
Time Frame: Within one week after surgery
|
R0 Resection rate
|
Within one week after surgery
|
The incidence of serious adverse events
Time Frame: Within 3 months after Last medication
|
Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 5.0.
|
Within 3 months after Last medication
|
QLQ-C30 score
Time Frame: up to 12 months
|
Quality of Life Questionnaire C30
|
up to 12 months
|
QLQ-C29 score
Time Frame: up to 12 months
|
Quality of Life Questionnaire C29
|
up to 12 months
|
Low Anterior Resection Syndrome (LARS)
Time Frame: up to 12 months
|
Low Anterior Resection Syndrome Questionnaire
|
up to 12 months
|
Quality of life and function assessment
Time Frame: up to 12 months
|
IIEF-5 (international questionnaire of erectile function-5)score
|
up to 12 months
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STARS-RC06
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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