Colorectal Carcinoma
Conditions
Brief summary
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.
Interventions
DRUGPD-1 antibody
Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)
Sponsors
Liaoning Cancer Hospital & Institute
Fudan University
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
PD-1
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who personally provided written consent for participation in the study * Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT * Primary rectal cancer histopathologically confirmed to be adenocarcinoma * Clinical stage of T3,and T4 ,N any,M0,before CRT * Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT * Patients with the ECOG performance status of 0 or 1 at the time of enrollment * Patients without distant metastasis on the imaging test before CRT * Preoperative biopsy of tumor immunohistochemistry TPS\>1% or CPS\>1 * Life expectancy of greater than 2 years * No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation * Hematology: WBC\>4000/mm3; PLT\>100000/mm3; Hb\>10g/dL * Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL * Renal function: creatinine \<1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease. * Have not received rectal surgery in the past; * Have not received chemotherapy or radiotherapy in the past; * Have not received biological treatment in the past; * Past endocrine therapy: unlimited.
Exclusion criteria
* Rectal cancer with unstable microsatellite (MSI or dMMR); * Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1 * Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA); * Autoimmune diseases; * Other active clinical serious infections (\>NCI-CTC version 3.0); * Patients in clinical phase I; * There is evidence that there is distant metastasis before surgery; * Cachexia, decompensation of organ function; * Have a history of pelvic or abdominal radiotherapy; * Multiple primary cancers; * Patients who need treatment for seizures (such as steroids or anti-epileptic treatment); * Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; * Chronic inflammatory bowel disease, intestinal obstruction; * Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results; * Known or suspected to be allergic to the study drug or to any drug given in connection with this test; * Any unstable conditions or situations that may endanger patient safety and compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 1 year | Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | 3 years |
| Overall survival (OS) | 3 years |
| Clinical complete response (CCR) | 1 year |
Countries
China
Outcome results
None listed