Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

Conditions

• Rare Tumour

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Albumin-Bound Paclitaxel — DRUG
  Albumin-Bound Paclitaxel 260mg/m2,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with albumin-bound paclitaxel if PDOs show the highest response to this drug under the guidance of MTB.
• Epirubicin — DRUG
  Epirubicin 90mg/m2,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with epirubicin if PDOs show the highest response to this drug under the guidance of MTB.
• Gemcitabine — DRUG
  Gemcitabine 1000mg/m2,D1,D8,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with gemcitabine if PDOs show the highest response to this drug under the guidance of MTB.
• Vinorelbine — DRUG
  Vinorelbine 25-30mg/m2,D1,D8,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with vinorelbine if PDOs show the highest response to this drug under the guidance of MTB.
• Cisplatin — DRUG
  Cisplatin 90mg/m2,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with cisplatin if PDOs show the highest response to this drug under the guidance of MTB.
• Irinotecan — DRUG
  Irinotecan 125mg/m2,D1,D8,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with irinotecan if PDOs show the highest response to this drug under the guidance of MTB.
• Fluorouracil — DRUG
  Fluorouracil 600mg/m2,D1-5,q3w Patients with advanced rare tumours who failed to standard treatment will be administrated with fluorouracil if PDOs show the highest response to this drug under the guidance of MTB.
• Nivolumab — DRUG
  Nivolumab 3mg/kg,q2w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with nivolumab under the guidance of MTB.
• Pembrolizumab — DRUG
  Pembrolizumab 200mg,q2w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with pembrolizumab under the guidance of MTB.
• Durvalumab — DRUG
  Durvalumab 10mg/kg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with durvalumab under the guidance of MTB.
• Atezolizumab — DRUG
  Atezolizumab 1200mg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with atezolizumab under the guidance of MTB.
• Sintilimab — DRUG
  Sintilimab 200mg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with sintilimab under the guidance of MTB.
• Tislelizumab — DRUG
  Tislelizumab 200mg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with tislelizumab under the guidance of MTB.
• Camrelizumab — DRUG
  Camrelizumab 200mg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with camrelizumab under the guidance of MTB.
• Toripalimab — DRUG
  Toripalimab 240kg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with toripalimab under the guidance of MTB.
• Serplulimab — DRUG
  Serplulimab 3mg/kg,q2w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with serplulimab under the guidance of MTB.
• Adebrelimab — DRUG
  Adebrelimab 20mg/kg,q3w Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with adebrelimab under the guidance of MTB.
• Envafolimab — DRUG
  Envafolimab 150mg,qw Patients with advanced rare tumours who failed to standard treatment carrying no targeted alterations will be administrated with envafolimab under the guidance of MTB.
• Osimertinib — DRUG
  Osimertinib 80mg,qd Patients with advanced rare tumours who failed to standard treatment carrying EGFR mutations will be administrated with osimertinib under the guidance of MTB.
• Alectinib — DRUG
  Alectinib 600mg,bid Patients with advanced rare tumours who failed to standard treatment carrying ALK fusion will be administrated with alectinib under the guidance of MTB.
• Vemurafenib — DRUG
  Vemurafenib 960mg,bid Patients with advanced rare tumours who failed to standard treatment carrying BRAF V600E mutation will be administrated with vemurafenib under the guidance of MTB.
• Pamiparib — DRUG
  Pamiparib 60mg,bid Patients with advanced rare tumours who failed to standard treatment carrying BRCA1/2 mutation will be administrated with pamiparib under the guidance of MTB.
• Pyrotinib — DRUG
  Pyrotinib 400mg, qd Patients with advanced rare tumours who failed to standard treatment carrying HER-2 mutation or HER-2 over expression/amplification will be administrated with Pyrotinib under the guidance of MTB.
• Imatinib — DRUG
  Imatinib 400mg, qd Patients with advanced rare tumours who failed to standard treatment carrying CKIT mutation will be administrated with imatinib under the guidance of MTB.
• Palbociclib — DRUG
  Palbociclib 125mg, 21/7 dosing schedule Patients with advanced rare tumours who failed to standard treatment following HR(+)/HER-2(-) will be administrated with palbociclib under the guidance of MTB.
• Savolitinib — DRUG
  Savolitinib 300mg, qd Patients with advanced rare tumours who failed to standard treatment carrying C-MET mutation will be administrated with savolitinib under the guidance of MTB.
• Entrectinib — DRUG
  Entrectinib 600mg, qd Patients with advanced rare tumours who failed to standard treatment carrying ROS-1 fusion or NTRK fusion will be administrated with entrectinib under the guidance of MTB.
• Other — DRUG
  Patients with advanced rare tumours who failed to standard treatment in RWS ICF Group will be administrated with empirical chemotherapy(e.g., "Albumin-Bound Paclitaxel", "Epirubicin", "Gemcitabine", "Vinorelbine", "Cisplatin", "Irinotecan", "Fluorouracil"), immunological(e.g., "Nivolumab", "Pembrolizumab", "Durvalumab", "Atezolizumab", "Sintilimab", "Tislelizumab", "Camrelizumab", "Toripalimab", "Serplulimab","Adebrelimab","Envafolimab") or targeted drugsl(e.g., "Osimertinib", "Alectinib", "Vemurafenib", "Vemurafenib", "Pyrotinib", "Imatinib", "Palbociclib", "Savolitinib", "Entrectinib")treatments.

Study Details

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Key Dates

Start date

Jan 1, 2025

Status verified

Nov 2024

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

200 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard treatment Group
  Patients with rare tumours in this group will undergo standard treatment in accordance with the leading domestic and international guidelines (NCCN/ESMO/CSCO/CACA) and clinical trial.
• Experimental: Criteria-Fulfilled ICF Group
  Intervention in this group is to perform PDOs culture and drug screening of lesions from patients with rare tumours who failed to standard treatment and fully meet the inclusion and exclusion criteria. The MTB will review the results of the drug screening and NGS, and subsequently determine the personalised chemotherapy, targeted or immunological agents.
• Experimental: Compassionate-Use ICF Group
  Patients with rare tumours who failed to standard treatment and do not meet the requisite criteria (e.g. active hepatitis B, underlying disease in the exclusion criteria, symptomatic brain metastases) will provide informed consent and undergo PDOs culture and drug screening. The MTB will review the results of the drug screening and NGS, and subsequently determine the personalised chemotherapy, targeted or immunological agents.
• Experimental: RWS ICF Group
  Patients with rare tumours who failed to standard treatment will be included in a real-world study cohort and receive clinically conventional treatment if they do not undergo PDOs culture and NGS testing successfully or are unwilling to base their treatment on the results of PDOs and NGS for various reasons.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

• shubin wang, Doctor
  +86 13823394076
  [email protected]