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To explore the safety and efficacy of neoadjuvant therapy for locally advanced rectal cancer with short course radiotherapy followed by camrelizumab combined with fluzoparib and chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCRT followed by camrelizumab combined with fluzoparib and chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCRT | Radiation | 5×5Gy,5Gy/d,QD,D1-D5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and grade according to NCI-CTCAE 5.0(including serious adverse events and immune-related adverse events); Surgical safety: surgical complications, 30 - and 90-day postoperative mortality, length of stay, and reoperation rate | up to 36 months |
| pCR (Pathological Complete Response) | The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes, also defined as the proportion of subjects with grade 0 in the AJCC Tumor Regression Grading (TRG) scoring system(version 8.0). | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Event-Free Survival(EFS) rate | The percentage of patients without disease recurrence or progression or death due to any cause after 3-year follow-up | up to 36 months |
| Overall Survival(OS) |
| Measure | Description | Time Frame |
|---|---|---|
| biomark | evaluate the relationship between potential biomarkers (including but not limited to MMR status, PD-L1 expression) and efficacy | up to 36 months |
Inclusion Criteria:
Patients who provided written informed consent form for participation in this study;
Aged 18-75 years old, male or female;
Histologically confirmed pathological diagnosis of proficient mismatch repair/microsatellite stable(pMMR/MSS) rectal adenocarcinoma;
The lower margin of the tumor is ≤10cm from the anal verge;
Clinical Stage (according to the 8th edition of AJCC) T3NanyM0 and confirmed on imaging to fulfil at least any of the following: (1)MRF (+),(2)EMVI(+),(3)LPLN(+);or T4NanyM0 with or without one of the above three;
Those who are expected to achieve R0 resection;
Able to swallow tablets normally;
Patients with the ECOG performance status of 0 or 1 at the time of enrollment;
Patients have not received any previous anti-tumor therapy for rectal cancer;
Planning to undergo surgery after completion of neoadjuvant therapy;
Have no contraindications to surgery;
Normal function of major organs, including:
Female subjects of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to initiation of study drug administration and to use effective contraception (e.g., intrauterine device, birth control pills, or condoms) during the trial period and for at least 3 months after the last dose of study drug; for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose of study drug; and for male subjects whose partner is a female of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose of study drug. Use effective contraception;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianglin Yuan | Contact | 13667241722 | xlyuan1020@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital, Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430079 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C000722917 | fluzoparib |
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| Camrelizumab | Drug | 200mg, D1, ivgtt, Q3W, C1-4 |
|
| Fluzoparib | Drug | 100mg, BID, PO, Q3W, C1-4 |
|
| CAPEOX | Drug | Capecitabine: 1000 mg/m2, BID, PO,D1-14, Q3W, C1-C4; Oxaliplatin: 130mg/m2, D1, ivgtt, 0-2h,Q3W,C1-4 |
|
The time from the date of randomization to the death caused by any cause
| up to 36 months |
| R0 resection rate | The rate of negative margin microscopically | up to 6 months |
| Completion rate of neoadjuvant therapy | the rate of NAT completion | up to 6 months |
| Tumor Regression grade (TRG) | Evaluated according to AJCC Version 8 TRG scoring system | up to 6 months |
| quality of life (QOL) | The EORTC QLQ-C30 scale was used | up to 36 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |