PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

PD-1 antibody + cox inhibitor

Tags

MSI-H/ MMRd

Comments

Trial only in China, for patients with advanced MSI-H/dMMR colorectal cancer. All patients receive a combination of anti-PD-1 monoclonal antibody (BAT1306) plus a COX inhibitor (aspirin, or celebrex when there is contraindication to aspirin).

Location Location Status
China
Gastrointestinal Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655
Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510655
Recruiting

Contacts

Yanhong Deng, M.D.
Contact
008613925106525 dengyanh@mail.sysu.edu.cn

Inclusion Criteria

Inclusion Criteria:

Signed informed consent; able to comply with study and/or follow- up procedures;
Age:18-75 years old;
Histological or cytological documentation of colorectal cancer;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
There must be documentation by CT scan, MRI, or intraoperative palpation that tumor is unresectable;
Have had at least one lines of chemotherapy fail or refuse to receive chemotherapy;
Histologically confirmed metastatic or primary colorectal cancer as dMMR/MSI-H or whole exon sequence confirmed tumor mutation burden higher than 1000;
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Hemoglobin (Hb) ≥ 90g/ L, absolute neutrophil count (ANC) ≥ 1.5×109/ L, platelet count ≥ 100×109/ L; Total bilirubin ≤ 1.5×the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 ×ULN; Serum creatinine ≤1.5×the ULN.

Exclusion Criteria

Exclusion Criteria:

Previous treatment with other therapy targeting T-cell costimulation or immune checkpoint pathways;
Active, known, or suspected autoimmune disease (except for type 1 diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, or conditions not expected to recur in the absence of an external trigger);
A previous cancer active within the previous 5 years;
Subjects with known allergy to the study drugs or to any of its excipients;
Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment;
Heart failure grade III/IV (NYHA-classification);
Patients with active infection within 1 week before enrollment (infection caused by fever above 38 °C);
Patients with severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema);
Patients with active gastrointestinal bleeding;
Patients with serious complications (intestinal obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders);
Psychiatric disease or a history of central nervous system disease that affects clinical treatment;
Receive other anti-tumor treatments (including anti-tumor immunotherapy, interventional therapy and intra-serosal injection of anti-tumor drugs) or participate in other interventional clinical trials within two weeks before enrollment;
Breast- feeding or pregnant women;
Lack of effective contraception;
The investigator determined that the patient was not eligible for this clinical trial.

NCT ID

NCT03638297

Date Trial Added

2018-08-20

Updated Date

2023-03-22