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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2030-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Advanced Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Involve-field radiotherapy-TNT+Camrelizumab

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.

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

Camrelizumab: 200mg

CAPOX

Intervention Type DRUG

CAPOX

Involve-field irradiation

Intervention Type RADIATION

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

TME surgery

Intervention Type PROCEDURE

TME surgery

Elective nodal irradiation-TNT

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.

Group Type OTHER

Capecitabine

Intervention Type DRUG

Capecitabine: 825mg/m2, bid;

CAPOX

Intervention Type DRUG

CAPOX

Elective nodal irradiation

Intervention Type RADIATION

Elective nodal irradiation: Large pelvic field

TME surgery

Intervention Type PROCEDURE

TME surgery

Interventions

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Capecitabine

Capecitabine: 825mg/m2, bid;

Intervention Type DRUG

Camrelizumab

Camrelizumab: 200mg

Intervention Type DRUG

CAPOX

Intervention Type DRUG

Involve-field irradiation

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

Intervention Type RADIATION

Elective nodal irradiation

Elective nodal irradiation: Large pelvic field

Intervention Type RADIATION

TME surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
4. Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
5. 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;
6. 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)；
7. 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;
8. Voluntary written informed consent and commitment to complete the full treatment and follow-up program.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No