Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer

Rectal Cancer Clinical Trial

Official title:

Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined With Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424692
• Other study ID #: PekingUMCHPTC
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2022
• Source: Peking Union Medical College Hospital
• Contact: Guole Lin
• Phone: 13801081483
• Email: linguole[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

Description:

The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.

The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.

The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 ~ 75 years old, regardless of gender

• Patients with colorectal cancer diagnosed by histopathology or cytology

• Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy

• Having at least one assessable tumor focus

• ECoG physical condition score = 2 points

• Voluntarily participate and sign informed consent

Exclusion Criteria:

• Patients diagnosed with metastasis

• Patients who cannot obtain tumor samples

• Pregnant and lactating women

• Patients with poor compliance

• Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment

• Patients with other malignant tumors

• Suffering from serious mental and nervous system diseases

• The researchers believe that patients should not be selected for this study

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colon Cancer
• Colorectal Neoplasms
• Rectal Cancer

Intervention

Drug:
• 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
Choose chemotherapeutic drugs(5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate) based on PTC drug sensitivity results.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Cassidy J, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzén F, Saltz L. Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol. 2008 Apr 20;26(12):2006-12. doi: 10.1200/JCO.2007.14.9898. — View Citation

de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000 Aug;18(16):2938-47. — View Citation

Gao H, Korn JM, Ferretti S, Monahan JE, Wang Y, Singh M, Zhang C, Schnell C, Yang G, Zhang Y, Balbin OA, Barbe S, Cai H, Casey F, Chatterjee S, Chiang DY, Chuai S, Cogan SM, Collins SD, Dammassa E, Ebel N, Embry M, Green J, Kauffmann A, Kowal C, Leary RJ, Lehar J, Liang Y, Loo A, Lorenzana E, Robert McDonald E 3rd, McLaughlin ME, Merkin J, Meyer R, Naylor TL, Patawaran M, Reddy A, Röelli C, Ruddy DA, Salangsang F, Santacroce F, Singh AP, Tang Y, Tinetto W, Tobler S, Velazquez R, Venkatesan K, Von Arx F, Wang HQ, Wang Z, Wiesmann M, Wyss D, Xu F, Bitter H, Atadja P, Lees E, Hofmann F, Li E, Keen N, Cozens R, Jensen MR, Pryer NK, Williams JA, Sellers WR. High-throughput screening using patient-derived tumor xenografts to predict clinical trial drug response. Nat Med. 2015 Nov;21(11):1318-25. doi: 10.1038/nm.3954. Epub 2015 Oct 19. — View Citation

Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol. 2004 Jan 1;22(1):23-30. Epub 2003 Dec 9. — View Citation

Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, Gansler T, Lerro C, Fedewa S, Lin C, Leach C, Cannady RS, Cho H, Scoppa S, Hachey M, Kirch R, Jemal A, Ward E. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41. doi: 10.3322/caac.21149. Epub 2012 Jun 14. Review. Erratum in: CA Cancer J Clin. 2012 Sep-Oct;62(5):348. — View Citation

Yin S, Xi R, Wu A, Wang S, Li Y, Wang C, Tang L, Xia Y, Yang D, Li J, Ye B, Yu Y, Wang J, Zhang H, Ren F, Zhang Y, Shen D, Wang L, Ying X, Li Z, Bu Z, Ji X, Gao X, Jia Y, Jia Z, Li N, Li Z, Ji JF, Xi JJ. Patient-derived tumor-like cell clusters for drug testing in cancer therapy. Sci Transl Med. 2020 Jun 24;12(549). pii: eaaz1723. doi: 10.1126/scitranslmed.aaz1723. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of 3-year disease-free survival rate of patients in both group	Follow-up the survival status of patients, and calculate 3-year disease-free survival rate of patients in both group	3 years
Secondary	The relation between TMB and clinical outcomes	Use tumor whole exon (WES) sequencing to detect the Tumor Mutation Burden (TMB) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.	3 years
Secondary	The relation between MSI and clinical outcomes	Use tumor whole exon (WES) sequencing to detect the Microsatellite Instability (MSI) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.	3 years
Secondary	The relation between dMMR and clinical outcomes	Use tumor whole exon (WES) sequencing to detect the Deficient Mismatch Repair (dMMR) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes.	3 years
Secondary	The difference of clinical outcomes of patients in both group	Follow-up the health status and weather tumor recurrence and metastasis of patients, and evaluate whether the test results of extended drug regimen correspond with clinical outcomes	3 years
Secondary	The difference of TTP of patients in both group	Follow-up the results of patients' periodic reviews and calculate Time To Progress (TTP) of patients in both group, and use survival analysis to detect whether the two group has difference in TTP.	3 years
Secondary	The difference of ORR of patients in both group	Follow-up the results of patients' periodic reviews and calculate Objective Response Rate (ORR) of patients in both group, and use survival analysis to detect whether the two group has difference in ORR.	three years
Secondary	The difference of DFS of patients in both group	Follow-up the results of patients' periodic reviews and calculate Disease Free Survival (DFS) of patients in both group, and use survival analysis to detect whether the two group has difference in DFS.	3 years
Secondary	The difference of PFS of patients in both group	Follow-up the results of patients' periodic reviews and calculate Progress Free Survival (PFS) of patients in both group, and use survival analysis to detect whether the two group has difference in PFS.	3 years
Secondary	The difference of OS of patients in both group	Follow-up the results of patients' periodic reviews and calculate Overall Survival (OS) of patients in both group, and use survival analysis to detect whether the two group has difference in OS.	3 years