Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHong Qiu

About this trial

The goal of this clinical trial is to learn if SHR-1701 combine with chemoradiotherapy works to treat severe CRC.

Participants will take:

Induction: SHR-1701 combined with CAPOX for one cycle. Radiotherapy: Short-course radiotherapy (SCRT) (25Gy/5F). Consolidation: SHR-1701 combined with CAPOX for five cycles, after which the subjects undergo TME surgery.

Eligibility criteria

Qualifiers

1: Sign the informed consent form and voluntarily participate in this study

Disqualifiers

Allergy to monoclonal antibody, SHR-1701, capecitabine, oxaliplatin and other platinum drugs

The patient previously received or is receiving any following treatments: a) Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc; b) Within 2 weeks before the first use of the study drug, is using immunosuppressive drugs or systemic hormone drugs to achieve immunosuppression (dose > 10mg/day prednisone or equivalent); in the absence of active autoimmune diseases, inhalation or local use of steroids and doses > 10mg/day prednisone or equivalent adrenal cortical hormones are allowed; c) Has received attenuated live vaccines within 4 weeks before the first use of the study drug; d) Has undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the study drug.

Having any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergy that has completely resolved and does not require any intervention after adulthood can be considered for inclusion, but patients who require medical intervention with bronchodilators cannot be included.

Have a history of immunodeficiency, including a positive HIV test result, or suffer from other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation.

Trial design

Treatments tested in this trial

  • SHR-1701 neoadjuvant

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hong Qiu

Lead sponsor

Tongji Hospital

Sponsor institution