Neoadjuvant SHR-1701 Plus Chemoradiotherapy for Locally Advanced Rectal Cancer

NCT07478731 | Recruiting Phase 2

• 1 other identifier: MA-CRC-II-018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CRC (Colorectal Cancer)

Outcome Measures

Primary Outcomes (1)

• pCR

  No residual viable tumor cells in either the primary tumor site or the lymph nodes

  At surgery (pathological assessment)

Secondary Outcomes (2)

• cCR

  At completion of neoadjuvant therapy (prior to surgery)

• OS

  From date of randomization until date of death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Drug: SHR-1701 neoadjuvant

Interventions

SHR-1701 neoadjuvant DRUG

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Sign the informed consent form and voluntarily participate in this study
• : Age 18-75
• : Pathologically confirmed rectal adenocarcinoma（At least meet any of the following criteria：cT3-4、cN2、EMVI+、MRF+）
• : pMMR or MSS/MSI-L rectal adenocarcinoma
• : The distance from tumor edge to the anal verge
• : Expect to complete R0 resection
• : Patients can swallow pills
• : ECOG PS 0-1
• : Patients has not received any anti-tumor treatment before, including surgery, radiotherapy, chemotherapy, targeting therapy and immunotherapy
• : Plan to complete surgery after neoadjuvant therapy
• : There is contraindication to surgery
• : Main organ function efficient, including blood routine examination, blood biochemical examination, coagulation function
• : Female subjects with reproductive capacity are required to undergo a serum pregnancy test 72 hours before starting the administration of the test drug, and the result must be negative. During the trial period and for at least 3 months after the last administration, they must take effective contraceptive measures (such as intrauterine devices, contraceptives, or condoms). For male subjects whose partners are female with reproductive capacity, effective contraceptive measures must be taken during the trial period and for at least 3 months after the last administration.

You may not qualify if:

• 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.
• 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.
• There are heart diseases or clinical symptoms that are not well controlled, including but not limited to: (1) NYHA grade II or above heart failure, (2) unstable angina pectoris, (3) having experienced myocardial infarction within the past year, (4) having clinically significant supraventricular or ventricular arrhythmias that have not been controlled through clinical intervention or remain poorly controlled even after clinical intervention.
• Within 4 weeks prior to the first use of the study drug, there was a severe infection (CTCAE \> grade 2), such as severe pneumonia, bacteremia, infection complications, etc required hospitalization; those with baseline chest imaging indicating active pulmonary inflammation, those who had symptoms and signs of infection or required oral or intravenous antibiotic treatment within 14 days prior to the first use of the study drug, excluding cases where antibiotics were used prophylactically.
• Those who were found to have active tuberculosis infection through medical history or CT examination, or those who had a history of active tuberculosis infection within the previous 1 year of enrollment, or those who had a history of active tuberculosis infection more than 1 year ago but did not receive proper treatment.
• There is active hepatitis B (with HBVDNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (with positive hepatitis C antibody and HCVRNA above the detection limit of the analytical method)
• Pregnant or lactating women
• Based on the researchers' assessment, there are other factors that could potentially lead to the premature termination of the study. These include having other serious illnesses (including mental disorders) that require combined treatment, alcohol abuse, drug abuse, family or social factors, which may affect the safety or compliance of the participants.

Sponsors & Collaborators

• Hong Qiu: lead

Study Sites (1)

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Qiu Hong

CONTACT

027 8366 2688; qiuhong@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: March 17, 2026
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From Study complement

Locations

CN (1)