Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT04831528

Ne recrute pas encore

Decision-making of ctDNA in Patients With mCRC After Failure of First-line Treatment Containing Cetuximab - a Single-center, Phase II Clinical Study

Observationnel

Phase non listée

Sponsor: Fudan University

Dernière synchronisation : 5 avril 2021
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site local.

This study aimis at detecting the genomic changes of ctDNA in patients of RAS and BRAF
wild-type mCRC, who failed after first line treatment containing cetuximab. According to the
results of ctDNA detection, individualized second-line targeted therapy strategies were
developed to explore the disease control rate and prognostic significance of ctDNA-guided
treatment for metastatic colorectal cancer.

Catégorie de traitement

Anticorps monoclonaux, Thérapie ciblée

Mutations requises

Aucun

Essai commencé

10 avril 2021

Dernière mise à jour par le sponsor

5 avril 2021

Achèvement estimé

30 juin 2026

Contact de l'étude

Nom:Zhiyu Chen, Professor

E-mail:chanhj75@aliyun.com

Téléphone:021-64175590

Éligibilité

Critères d'inclusion

1. Age ≥18, gender unlimited;

2. Proven histologically by colorectal adenocarcinoma, local lesions can not be radical resection or metastatic colorectal cancer;

3. Patients with RAS and BRAF wild-type tissue genetic testing, receiving first-line treatment containing cetuximab, and radiographic evaluation of disease progression;

4. Eastern Cooperative Oncology Group (ECOG) physical condition score (PS) 0 ~ 2;

5. Expected survival of more than 3 months;

6. Within 7 days before screening (including 7 days), laboratory test data requirements were as follows: neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), serum total bilirubin ≤1.25 times the upper normal limit (ULN);ALT and AST≤ 2.5 x ULN (≤5x ULN in patients with liver metastasis);Serum creatinine ≤1.0 x ULN and creatinine clearance rate ≥60 mL /min;Left ventricular ejection fraction in ultrasound examination >55%;

7. At least one measurable lesion (RECIST 1.1 criteria);

8. Subjects (or their legal representative/guardian) must sign the informed consent indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.

Critères d'exclusion

Those who have one or more of the following will not be included in the study:

1. Have received any experimental drugs or anti-tumor drugs within 4 weeks before enrollment;

2. A history of other tumors in the past five years, except for cervix cancer or basal cell carcinoma of the skin that has been cured;

3. Patients with obvious intracranial hypertension or neuropsychiatric symptoms due to uncontrolled primary brain tumor or central nerve metastatic tumor

4. Pregnant or lactating women;Those who are fertile but do not take adequate contraceptive measures;

5. Alcoholism or drug addiction;

6. with pleural effusion or ascites, causing respiratory syndrome (≥CTCAE2 grade dyspnea), requiring local treatment;

7. Patients with the following serious or uncontrolled diseases: severe heart disease, unstable condition after treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment;Definite neuropathy or psychosis, including dementia or seizures;Severe or uncontrolled infections;Patients with active and disseminated intravascular coagulation and significant bleeding tendency

8. known hypersensitivity or anaphylaxis to any component of the study drug to be applied.

9. The function of important organs is obviously impaired

10. Other circumstances under which the investigator considers that the patient should not participate in the study

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Détails de la conception

AllocationN/A

Modèle d'interventionN/A

MasquageN/A

Nombre à inscrire100

Bras et interventions

Bras

Interventions

Type :

Description :

Interventions :

Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others

Mesures des résultats

Mesures des résultats primaires

Objective response rateApril 10,2021-June 30,2021

The percentage of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including patients with CR and PR.Objective tumor response was assessed using the Response Assessment Criterion for Solid Tumors (RECIST 1.1).

Mesures des résultats secondaires

overall survivalApril 10,2021-June 30,2021

Time from enrollment to death from any cause.Lost visitors to the last follow-up time.

progress free survivalApril 10,2021-June 30,2021

Patients were randomized to solstice for any recorded time of tumor progression or death from any cause.

Safety and tolerabilityApril 10,2021-June 30,2021

NCI -- CTC AE 4.0 will be used to evaluate the clinical safety of the treatment in the study.The incidence of adverse events in the subjects should be assessed at each clinical visit.

duration of responseApril 10,2021-June 30,2021

This is the time between the first assessment of a tumor as CR or PR and the first assessment as PD or death from any cause.

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