PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer
Phase 2
Active, not recruiting
- Conditions
- Colorectal Carcinoma
- Interventions
- Drug: PD-1 antibody
- Registration Number
- NCT04833387
- Lead Sponsor
- Sun Yat-sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD-1 antibody + capecitabine + radiation PD-1 antibody -
- Primary Outcome Measures
Name Time Method Pathological complete response 1 year Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
- Secondary Outcome Measures
Name Time Method Relapse-free survival (RFS) 3 years Overall survival (OS) 3 years Clinical complete response (CCR) 1 year
Trial Locations
- Locations (1)
651 Dongfeng Road East
🇨🇳Guangzhou, Guangdong, China