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Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies (GENE)

17 mai 2026 mis à jour par: Yifan Tong, PhD, Sir Run Run Shaw Hospital

The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence

This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This trial is a single-arm interventional clinical study to evaluate the efficacy and safety of neoadjuvant gemcitabine-cisplatin plus Envafolimab in resectable biliary tract malignancies patients with high-risk of recurrence. Patients with high-risk factors for recurrence. The criteria were defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U/mL; b. Tumor diameter ≥5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade. The primary endpoint: Major Pathologic Response (MPR). Secondary endpoints: Overall Survival (OS), Disease-free survival (DFS), Objective Response Rate (ORR) per the Response Evaluation Criteria In Solid Tumors (RECIST v1.1), Pathologic Response Rate (PCR), and R0 resection rate. The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and laboratory test abnormalities judged as per the CTCAE v5.0 criteria. Exploratory endpoint: Relationship between carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 125 (CA125), Pathological biomarker expression, spatial transcriptome (if samples are sufficient), gut microbiome metagenome sequencing, and treatment response.

Type d'étude

Interventionnel

Inscription (Estimé)

34

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Yifan Tong, Ph.D
  • Numéro de téléphone: 86 571 86006271
  • E-mail: tongyf@zju.edu.cn

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Participants who have signed a written Informed Consent Form (ICF);
  • Male or female participants aged 18-80 years;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0/1;
  • Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment;
  • Participants must meet the following requirements for major vital organ function: a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count ≥ 90×10⁹/L; hemoglobin ≥ 9 g/dL; b. Coagulation function: international normalized ratio (INR) ≤ 1.2; c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); d. Serum albumin ≥ 3.5 g/dL; total bilirubin ≤ 1.5 times the ULN. Patients with obstructive jaundice who meet the eligibility criteria after percutaneous transhepatic cholangial drainage or endoscopic retrograde cholangiopancreatography treatment are also eligible for enrollment; e. Child-Pugh class A or B; f. Serum creatinine ≤ 1.5 times the ULN;
  • Patients with high-risk factors for recurrence. The criteria are defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U/mL; b. Tumor diameter ≥ 5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade;
  • Participants who have at least 1 measurable lesion (RECIST v1.1);
  • Be able to provide fresh stool samples and liver samples if undergoing surgery.

Exclusion Criteria

  • Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components;
  • Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy;
  • History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years;
  • Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded;
  • Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunctions that would preclude tolerance of general anesthesia or hepatectomy;
  • Women who are breastfeeding or pregnant;
  • Any other factors that, in the investigator's judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: GC Chemotherapy Plus Envafolimab Arm
Participants first receive GC chemotherapy plus envafolimab every 3 weeks (Q3W) for a total of 3 cycles (each cycle is 21 days). Eligibility for surgery is then assessed; eligible patients undergo radical resection.
Médicament: Neoadjuvant therapy followed by surgery

First:

Envafolimab: 400 mg on Day 1, repeated every 3 weeks (Q3W). GC chemotherapy: Gemcitabine: 1000 mg/m2 in 100 mL of 0.9% sodium chloride injection, administered intravenously over 30 minutes on Days 1 and 8, repeated Q3W. Cisplatin: 25 mg/m2 in 500 mL of 5% glucose injection, administered intravenously over 2 hours on Day 1 and 8, repeated Q3W.

Of note, no target drugs is involved.

Second:

Radical resection eligibility will be assessed by the investigator; those with indeterminate resectability require additional MDT discussion confirmation. The criteria for radical resection:

  1. No invasion of the main trunk of the hepatic vein, portal vein, or inferior vena cava;
  2. No distant metastasis except for hilar lymph node metastases;
  3. Minimum distance between surgical margin and tumor border ≥ 0.5 cm;
  4. Residual liver volume ≥ 30% (≥ 40% for participants with cirrhosis).
Autres noms:
  • Envafolimab, Gemcitabine, Cisplatin; Neoadjuvant GC-Envafolimab for Resectable Biliary Tract Malignancies

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Major Pathologic Response (MPR)
Délai: From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
MPR is defined as ≤10% residual viable tumor cells in the primary lesion and regional lymph nodes following neoadjuvant therapy, with Pathologic Response Rate (PCR, 0% viable tumor cells) included in the MPR definition.
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Residual viable tumor cell ratio
Délai: From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
Postoperative resected specimens are analyzed via pathological section to determine the residual viable tumor cell ratio
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
Objective Response Rate (ORR)
Délai: From enrollment until 2-4 weeks after completion of neoadjuvant therapy (three cycles, each cycle is 21 days)
ORR is defined as the sum of Complete Response (CR) and Partial Response (PR), representing the proportion of participants with sustained tumor regression meeting predefined criteria.
From enrollment until 2-4 weeks after completion of neoadjuvant therapy (three cycles, each cycle is 21 days)
Pathologic Response Rate (PCR)
Délai: From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
No viable tumor cells are found in the review of pathological sections.
From enrollment to 2-4 weeks after completion of thrid cycle (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
R0 resection
Délai: From enrollment to 2-4 weeks after completion of thrid cycles (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
R0 resection rate refers to the proportion of patients achieving complete surgical resection with negative margins.
From enrollment to 2-4 weeks after completion of thrid cycles (each cycle is 21 days) of neoadjuvant therapy, surgical pathological findings will be obtained, or patients will be assessed as unresectable.
Overall Survival (OS)
Délai: From enrollment up to 2 years following treatment initiation
OS is defined as the time from participant receiving the first treatment until death from any cause.
From enrollment up to 2 years following treatment initiation
Disease-free survival (DFS)
Délai: From enrollment up to 2 years following treatment initiation
DFS is defined as the time from the date of surgery to neoplasm recurrence or death for participants without residual lesions after surgery, whichever occurs first.
From enrollment up to 2 years following treatment initiation

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Biomarker Evaluation
Délai: From enrollment until 2 years after treatment
Correlations between these biomarkers (including CEA, CA19-9, CA125, spatial transcriptome, and gut microbiome metagenomic sequencing) and overall treatment efficacy, as well as subsequent basic research, are permitted.
From enrollment until 2 years after treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sir Run Run Shaw Hospital

Les enquêteurs

  • Chercheur principal: Yuelong Liang, Ph.D, Sir Run Run Shaw Hospital, Schoole of Medicine, Zhejiang University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 mai 2026

Achèvement primaire (Estimé)

30 mars 2028

Achèvement de l'étude (Estimé)

30 mars 2030

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

17 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SRRSH

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

After study completion and publication of study results, other individuals or groups may apply to the study executive committee for data sharing.

Délai de partage IPD

After study completion and publication of study results

Critères d'accès au partage IPD

Medical institutions & personnel, non-commercial use

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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