Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT07057089

Recrutement en cours

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

Interventionnel

Phase 2

the Fourth Hospital of Hebei Medical University

Sponsor: Hebei Medical University Fourth Hospital

Dernière synchronisation : 14 août 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

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.

Catégorie de traitement

Procédure, Chimiothérapie, Inhibiteurs de points de contrôle, Autres médicaments, Autres non-médicaments

Mutations requises

Aucun

Essai commencé

1 juillet 2025

Dernière mise à jour par le sponsor

14 août 2025

Achèvement estimé

1 mars 2028

Contact de l'étude

Nom:Fengpeng Wu, Professor

E-mail:wfpzhj@126.com

Téléphone:15032818011

Éligibilité

Critères d'inclusion

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.

Critères d'exclusion

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.

Pensez-vous que cet essai apparaît incorrectement ?

Détails de la conception

AllocationRandomized

Modèle d'interventionParallel Assignment

MasquageNone (Open Label)

Nombre à inscrire90

Bras et interventions

Bras

Interventions

Type : Experimental

Description : 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.

Interventions :

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

Mesures des résultats

Mesures des résultats primaires

CR ratewithin 5 weeks

CR defined as patient achieving pCR and cCR.

Mesures des résultats secondaires

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

Mettre l'essai en favori

Partager l'essai

Télécharger l'essai

Pensez-vous que cet essai apparaît incorrectement ?

Signaler l'essai

Télécharger l'essai

Sites d'essai

Cette étude compte 1 site d'essai

the Fourth Hospital of Hebei Medical University

Shijiazhuang, CN

Nom:Fengpeng Wu

Recrutement en cours

Shijiazhuang, CN

the Fourth Hospital of Hebei Medical University

Loading Maps...