Rectal cancer
Conditions
Interventions
After preoperative chemoradiotherapy, nivolumab(240mg) or nivolumab(240mg) plus ipilimumab (3 mg/kg) will be administered, and then radical surgery will be performed.
Sponsors
National Cancer Center Hospital East
Project of Translational and Clinical Research Core Centers
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Phase 1b part and the cohort A,D:primary rectal cncer 1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge 2. Clinical stage of T3-4 N-any M0 3. Age of >= 20 to < 80 years -The cohort B:local recurrence rectal cancer 1. Clinically diagnosed recurrent rectal cancer in the pelvis 2. The tumor is thought to be resectable by the imaging before CRT 3. Age of >= 20 to =< 75 years -The cohort C:First rectal cncer wirh resectable lung or liver metastases 1. Treatment-naive patients with rectal cancer, located within 12cm from their anal verge. 2. Clinical stage of T3-4 N-any M1a 3. Metastatic liver or lung tumors have been diagnosed clinically resectable 4. Age of >= 20 to < 80 years -Common criteria: 1. ECOG PS of 0 or 1 2. 50.4 Gy of concurrent pre-CRT completed with daily 1,650 mg/m2 of capecitabine 3. CRT-associated AEs will be recovered to grade =< 1 when study treatment starts 4. Sufficient organ functions
Exclusion criteria
Exclusion criteria: 1.Active multiple cancers . 2.Pts with a history of pelvic radiation. 3.Pts with a history of inflammatory bowel disease. 4.Pts with a history of pneumonitis or ILD. 5.Pts with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease. 6.Pts requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study. 7.Pts with a history of thyroid dysfunction. 8.Pts with a history or finding of cardiovascular risk falling into any of the following: ?left ventricular ejection rate below 50percent EF. ?history or finding of clinically significant, poorly controlled arrhythmia; exception: patients with well-controlled atrial fibrillation for more than 30 days before enrollment may be enrolled. ?history of acute coronary syndrome, coronary angioplasty, or stent placement within 6 months before enrollment. ?history or class II or more severe congestive heart failure according to NYHA . ?treatment-resistant hypertension.SP>140,DBP>90mmHG ?Pts wearing an implantable cardioverter defibrillator or permanent pacemaker. 9.Pts with poorly controlled diabetes mellitus or other diseases possibly interfering with toxicity evaluation. 10.Pts who are positive for any of the following: HIV-1and2 antibody,HTLV-1 antibody, HBs antigen,HCV antibody test. HBV-DNA above detection sensitivity will be also excluded. 11.Pts who are pregnant or lactating or who may be pregnant. 12.Pts with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study. 13.history of treatment with nivolumab. 14.Pts who are not willing to or incapable of complying with the procedures specified in the protocol. 15.Pts cannot agree ICF. 16.Pts who are determined by the investigator to be unsuitable as a subject for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Objective Response rate(ORR) - Mode of recurrence - Disease-free survival(DFS) - Overall survival (OS) - Adverse event (AE) - Rate of completing the protocol therapy Rate of radical resection for patients with primary resectable rectal cancer - Macroscopic evaluation of the resected specimen of primary rectal cancer - Intraoperative safety evaluation - Postoperative safety evaluation | — |
Countries
Japan
Contacts
Public ContactYuichiro Tsukada
National Cancer Center Hospital East Division of Colorectal Surgery
Outcome results
None listed