Status:
ACTIVE_NOT_RECRUITING
LIQUID BIOPSY FOCUSING ON CIRCULATING TUMOR CELLS AND CIRCULATING TUMOR DNA AS PRECISION MEDICINE IN GASTROINTESTINAL TUMORS
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Fundação Amaral Carvalho, Brazil
Conditions:
Cancer of Rectum
Cancer of Pancreas
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective, observational, multicenter cohort study. Our main objective is to to evaluate the use of CTCs and ctDNA with prognostic factors in locally advanced rectal tumors treated with to...
Detailed Description
To evaluate CTCs we will isolate cells from blood of patients by ISET method (Rarecells, France). The DNA from CTCs will be evaluated by digital PCR (Qiagen). Also, the ctDNA. Patients will be evaluat...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- • Age ≥ 18 years;
- For locally advanced rectal cancer:
- Patients with histological confirmation of adenocarcinoma of the distal rectum who are candidates for sphincter preservation and undergoing TNT, a long-course CRT regimen, followed by CT (5-FU + consolidation oxaliplatin);
- Tumors with a location that requires rectal amputation, except for very early tumors (cT1N0);
- Absence of distant metastases (M0).
- For locally advanced or metastatic stomach cancer:
- Patients with histological confirmation of adenocarcinoma of the stomach or esophagogastric junction (EGJ) (cT2-4, cN0-3, M0-1) who have not undergone any previous treatment for the disease, surgical or systemic;
- Patients who will undergo the following treatments:
- (T2 to T4, N+ and M0): 4 cycles of FLOT, surgery, + 4 cycles of FLOT (5-Fluorouracil, Oxaliplatin and Docetaxel);
- Initial cases: T2 to T4 N0: Surgery followed by adjuvant chemotherapy: CAPOX (capecitabine + oxaliplatin) or FOLFOX (5-Fluorouracil + capecitabine) - 8 cycles;
- Initially unresectable T4N3: If PDL1+ and CPS \> 5: CT (FOLFOX or XELOX) + nivolumab. If HER-2 + XELOX or FOLOFX + transtuzumab - after 8 cycles evaluate resectability;
- Metastatic disease: if HER2 negative - XELOX or FOLFOX with Nivolumab or pembrolizumab. If HER2 positive XELOX or FOLFOX with trastuzumab + pembrolizumab.
- For localized or metastatic pancreatic cancer:
- Patients with histologically confirmed pancreatic adenocarcinoma (cT1-4, N0-2, M0-1) who have not undergone any prior surgical or systemic treatment for the disease.
- Patients who will undergo the following treatments:
- T1 to T3, N0 to N2 - resectable: Surgery followed by 12 cycles of FOLFIRINOX (oxaliplatin, 5-fluorouracil and irinotecan)
- Borderline resectable: Neoadjuvant chemotherapy with FOLFIRINOX for 8 cycles and surgery
- Unresectable disease - locally advanced: FOLFIRINOX for 12 cycles or Gemcitabine + nanoparticle paclitaxel for 8 cycles
Exclusion
- Mid-rectum tumors or tumors with microsatellite instability.
- Stomach tumors or early EGJ (cT1N0)
- Patients who have undergone prior treatment or any surgical intervention in the last 30 days.
Key Trial Info
Start Date :
January 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 10 2026
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT06940778
Start Date
January 10 2025
End Date
December 10 2026
Last Update
April 27 2025
Active Locations (1)
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1
Hcor
São Paulo, São Paulo, Brazil, 04004-030