Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05601505

Rekrutiert

CINTS-R: Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer

Interventionsstudie

Phase 2

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,

Sponsor: Peking Union Medical College Hospital

Zuletzt aktualisiert: 25. März 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere

Erforderliche Mutationen

Keine

Studie gestartet

3. Februar 2023

Zuletzt vom Sponsor aktualisiert

25. März 2025

Voraussichtlicher Abschluss

31. Oktober 2025

Studienkontakt

Name:Lin guole, Doctor

E-Mail:linguole@126.com

Telefon:13801081483

Eignung

Einschlusskriterien

1. Aged 18-75 years;

2. ECOG score 0-2;

3. Rectal adenocarcinoma confirmed by pathology;

4. The lower margin of the tumor was less than 12cm from the anal margin;

5. Patients with clinical stage cT3-4N0M0 or cTanyN+M0;

6. Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery;

7. Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery;

8. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.

Ausschlusskriterien

1. ECOG score > 2;

2. Patients with multiple primary colorectal cancers;

3. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;

4. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;

5. pregnant or lactating women;

6. Patients with a history of severe mental illness, immune disease, hormone medication;

7. Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery;

8. Participated in other clinical researchers in the past 3 months;

9. Any other circumstances that the investigator considers inappropriate for inclusion.

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Design-Details

ZuteilungRandomized

InterventionsmodellParallel Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer470

Arme & Interventionen

Arme

Interventionen

Typ: No Intervention

Beschreibung: Eligible patients randomized into arm A will receive traditional neoadjuvant chemoradiotherapy, including long-course radiotherapy with a total number of 45-50.4Gy in 25-28 fractions, and with concurrent 3 times of oral capecitabine, the strategies of capecitabine are: During radiotherapy: capecitabine 1650mg/m2/d, orally administered twice a day, d1-d14, every 3 weeks as a course; During the non-radiotherapy period: capecitabine 2000mg/m2/d, orally administered twice daily, d1-d14, every 3 weeks as a course

Interventionen:

circulating tumor DNA

Ergebnismessungen

Primäre Ergebnismessungen

two-year disease-related treatment failure, 2y-DrTF2 years

the incidence of any of the following events occurring after treatment: identification of distant metastasis or progression to unresectable disease before surgery, non-radical resection of the primary tumour, local recurrence or distant metastasis after radical surgery, new primary colorectal tumour, or treatment-related death.

Sekundäre Ergebnismessungen

Time to recurrence, TTR2 years

The median time from randomization to the first observation of recurrence.

Two-year overall survival, 2yOS2 years

Refers to the proportion of patients still alive at 2 years after surgery

two-year disease-free survival (2yDFS)2 years

the percentage of patients who remain free of cancer recurrence or death from any cause two years after surgery.

clinical complete response (cCR) and near complete response (ncCR) rateup to 1 year

cCR and ncCR rate evaluated based on comprehensive examinations according to NCCN guidelines.

pathologically complete response (pCR) rateup to 1 year

the percentage of patients who are assessed as pathologically complete response (pCR) by pathologist.

pathological tumour regression grade (pTRG)up to 1 year

pathological tumor regression grade which is determined according to the criteria of the American Joint Committee on Cancer (AJCC) 8th edition

Quality of life assessment (QoL)5 years

it will be assessed by European Organization for Research and Treatment of Cancer (EORTC) questionnaires at each follow-up visit.

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Studienzentren

Diese Studie hat 1 Studienzentrum

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,

Beijing, Beijing, CN

Name:Lin guole, doctor

Rekrutierend

Beijing, Beijing, 100005 CN

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,

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