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

Not Applicable

Recruiting

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Drug: Camrelizumab; Drug: Capecitabine; Drug: CAPOX; Radiation: Involve-field irradiation; Radiation: Elective nodal irradiation; Procedure: TME surgery

• Registration Number: NCT07057089
• Lead Sponsor: Hebei Medical University Fourth Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Study Start: 2025-07-01
• Study First Posted: 2025-07-09
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-14
• Primary Completion: 2028-03-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Involve-field radiotherapy-TNT+Camrelizumab	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.
Involve-field radiotherapy-TNT+Camrelizumab	CAPOX	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.
Involve-field radiotherapy-TNT+Camrelizumab	Involve-field irradiation	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.
Involve-field radiotherapy-TNT+Camrelizumab	TME surgery	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.
Elective nodal irradiation-TNT	CAPOX	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.
Elective nodal irradiation-TNT	Capecitabine	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.
Elective nodal irradiation-TNT	Elective nodal irradiation	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.
Elective nodal irradiation-TNT	TME surgery	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.

Primary Outcome Measures

Name	Time	Method
CR rate	within 5 weeks	CR defined as patient achieving pCR and cCR.

Secondary Outcome Measures

Name	Time	Method
MPR rate	within 3 weeks after surgery	MPR defined as patients achieving a major pathological response after surgery.
R0-resection rate	within 3 weeks after surgery	R0-resection defined as patients without tumor cell infiltration in the tissue 1mm from the resection margin
Preservation rate of adjacent invaded organs	within 3 weeks after surgery	The involved organs were successfully preserved during the operation
ORR	within 5 weeks	Defined as the percentage of complete response (CR) and partial response (PR) to tumor volume reduction according to RECIST v1.1 criteria
3-year Event Free Survival	3 years	EFS defined as time from randomization to objectively observed tumor progression (local recurrence, new disease, or distant metastasis), development of a second malignancy, or death (death from any cause).
3-year OS	3 years	OS defined as time from randomization to death from any cause.
Incidence of adverse reactions	1 year	Occurrence of adverse reactions during therapy

Trial Locations

Locations (1)

the Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China