Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT07057089

Reclutamento in corso

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

Interventistico

Fase 2

the Fourth Hospital of Hebei Medical University

Sponsor: Hebei Medical University Fourth Hospital

Ultimo Aggiornamento: 14 agosto 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Categoria di Trattamento

Procedura, Chemioterapia, Inibitori dei Checkpoint, Altri Farmaci, Altri Non-Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

1 luglio 2025

Ultimo Aggiornamento dello Sponsor

14 agosto 2025

Completamento Stimato

1 marzo 2028

Contatto dello studio

Nome:Fengpeng Wu, Professor

Email:wfpzhj@126.com

Telefono:15032818011

Idoneità

Criteri di Inclusione

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.

Criteri di Esclusione

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.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare90

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: 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.

Interventi:

TME surgery
Capecitabine
Camrelizumab
CAPOX
Involve-field irradiation
Elective nodal irradiation

Misure di Esito

Misure di Esito Primarie

CR ratewithin 5 weeks

CR defined as patient achieving pCR and cCR.

Misure di Esito Secondarie

MPR ratewithin 3 weeks after surgery

MPR defined as patients achieving a major pathological response after surgery.

R0-resection ratewithin 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 organswithin 3 weeks after surgery

The involved organs were successfully preserved during the operation

ORRwithin 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 Survival3 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 OS3 years

OS defined as time from randomization to death from any cause.

Incidence of adverse reactions1 year

Occurrence of adverse reactions during therapy

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Siti dello Studio

Questo studio ha 1 sito

the Fourth Hospital of Hebei Medical University

Shijiazhuang, CN

Nome:Fengpeng Wu

In fase di reclutamento

Shijiazhuang, CN

the Fourth Hospital of Hebei Medical University

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