Actively Recruiting
Clinical Exploration of Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer: a Prospective, Open-label, Randomized Controlled Trial (Neo-Field I)
Led by Hebei Medical University Fourth Hospital · Updated on 2025-08-14
90
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of involved-field radiotherapy combined with total neoadjuvant therapy (TNT) and PD-1 inhibitors in patients with pMMR locally advanced rectal cancer. This Phase 2 randomized trial aims to compare this approach to elective nodal irradiation-TNT in treating this type of rectal cancer. The study is sponsored by Hebei Medical University Fourth Hospital and seeks to explore how these treatments impact clinical complete response and other outcomes. Participants are assigned to one of two groups. One group receives involved-field radiotherapy at 25 Gy over 5 fractions targeting the rectal tumor and nearby lymph nodes, followed by four cycles of CAPOX chemotherapy plus camrelizumab starting 1 to 2 weeks after chemoradiotherapy. The other group receives a longer course of elective nodal irradiation at 50.4 Gy over 28 fractions with oral capecitabine during radiotherapy, followed by four cycles of CAPOX chemotherapy. After treatment, patients are assessed 2 to 3 weeks later for clinical complete response (cCR); those meeting cCR criteria may choose surgery or observation, while others are recommended surgery or additional chemotherapy with camrelizumab if surgery is refused. During the study, participants undergo evaluations to measure response rates, surgical outcomes, organ preservation, and survival over up to three years. Safety and adverse reactions are monitored for one year. Assessments include clinical examinations, imaging, laboratory tests, and follow-up visits to track disease status and treatment effects. The main outcome measured is the complete response rate within 5 weeks, with secondary outcomes including major pathological response, R0 resection rate, organ preservation, objective response rate, event-free survival, overall survival, and adverse event incidence.
CONDITIONS
Brief Title
Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Pathologic diagnosis of adenocarcinoma of the rectum with confirmed pMMR type
- Clinical staging of T3-4NanyM0 or T1-2N+M0 based on AJCC 8th edition
- Primary tumor lower margin below peritoneal reflex or within 10 cm from anal verge
- Laboratory indicators within specified ranges for blood counts, liver and kidney function, and coagulation
- Agreement to use effective contraception during study and for 6 months after last treatment if of childbearing potential
- Voluntary written informed consent and commitment to complete treatment and follow-up
You will not qualify if you...
- Pathologic types other than adenocarcinoma such as neuroendocrine or squamous carcinoma
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Active infections including HIV or hepatitis B/C requiring antiretroviral therapy
- Severe cardiovascular diseases including recent myocardial infarction or uncontrolled hypertension
- History of other malignant tumors except certain cured cancers over 5 years ago
- Uncontrolled diabetes mellitus or abnormal thyroid function requiring medication
- Severe chronic bowel diseases such as Crohn's disease or active ulcerative colitis
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks including radiotherapy and chemotherapy cycles
Participants receive involved-field radiotherapy or elective nodal irradiation combined with chemotherapy and PD-1 inhibitor according to their assigned group.
Multiple visits over 5 weeks for radiotherapy and 4 cycles of chemotherapy plus Camrelizumab
Duration - Within 2 to 3 weeks after treatment completion
Participants who do not meet clinical complete response criteria are recommended to undergo TME surgery. Those who meet criteria may choose surgery or continue chemotherapy.
1 to 2 visits depending on surgery decision
Duration - Up to 3 years
Participants are monitored for treatment response, adverse events, and long-term outcomes including survival.
Periodic visits for up to 3 years
Trial Site Locations
Total: 1 location
1
the Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Actively Recruiting
Research Team
F
Fengpeng Wu, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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