Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)

NCT07057089 | Recruiting Phase 2

• 1 other identifier: ARK-Rectal cancer-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• CR rate

  CR defined as patient achieving pCR and cCR.

  within 5 weeks

Secondary Outcomes (7)

• MPR rate

  within 3 weeks after surgery

• R0-resection rate

  within 3 weeks after surgery

• Preservation rate of adjacent invaded organs

  within 3 weeks after surgery

• ORR

  within 5 weeks

• 3-year Event Free Survival

  3 years

Study Arms (2)

Involve-field radiotherapy-TNT+Camrelizumab

EXPERIMENTAL

Patients received Involve-field radiotherapy (25Gy/5f, including the primary rectal tumor, metastatic or suspected pelvic lymph nodes, mesorectal, and presacral regions). Four cycles of CAPOX plus Carilizumab were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy combined with camrelizumab.

Drug: Camrelizumab; Drug: CAPOX; Radiation: Involve-field irradiation; Procedure: TME surgery

Elective nodal irradiation-TNT

OTHER

Patients received elective nodal long-course concurrent chemoradiotherapy (50.4 Gy/28f). Capecitabine (825 mg/m² bid) was administered orally on radiotherapy days. Four cycles of CAPOX were given to patients 1-2 weeks after chemoradiotherapy completion. Patients were evaluated 2-3 weeks after the end of treatment. Patients who met the cCR criteria could choose to undergo surgical treatment or not. For patients who did not meet the cCR criteria, surgical treatment was recommended. For patients who refused surgery, the patients in the trial group continued to receive 4 cycles of CAPOX chemotherapy.

Drug: Capecitabine; Drug: CAPOX; Radiation: Elective nodal irradiation; Procedure: TME surgery

Interventions

Capecitabine DRUG

Capecitabine: 825mg/m2, bid;

Elective nodal irradiation-TNT

Camrelizumab DRUG

Camrelizumab: 200mg

Involve-field radiotherapy-TNT+Camrelizumab

CAPOX DRUG

CAPOX

Elective nodal irradiation-TNT; Involve-field radiotherapy-TNT+Camrelizumab

Involve-field irradiation RADIATION

Involve-field irradiation: Primary rectal tumor + metastatic or suspicious pelvic lymph nodes, mesorectal region, and presacral region

Involve-field radiotherapy-TNT+Camrelizumab

Elective nodal irradiation RADIATION

Elective nodal irradiation: Large pelvic field

Elective nodal irradiation-TNT

TME surgery PROCEDURE

TME surgery

Elective nodal irradiation-TNT; Involve-field radiotherapy-TNT+Camrelizumab

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
• Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
• The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;
• Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L; 2)Liver and kidney function: ALT/AST ≤ 2.5 x ULN, total bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60mL/min (Cockcroft-Gault formula)； 3)Coagulation: INR ≤ 1.5, APTT ≤ 1.5 x ULN (for those not receiving anticoagulation)；
• Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;
• Voluntary written informed consent and commitment to complete the full treatment and follow-up program.

You may not qualify if:

• Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
• Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
• Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
• Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
• Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg)；
• History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；
• Uncontrolled diabetes mellitus (HbA1c \> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；
• Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; camrelizumab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Fengpeng Wu

  Hebei Medical University Fourth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengpeng Wu, Professor

CONTACT

15032818011; wfpzhj@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 14, 2025

Record last verified: 2025-06

Locations

CN (1)