Status:
COMPLETED
Rechallenge of Prior Regimen in Third or Later-line Chemotherapy in Metastatic Colorectal Cancer
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Henan Cancer Hospital
Conditions:
Metastatic Colorectal Cancer
Chemotherapy Effect
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a single-arm, open-label, single-center prospective phase II study to evaluate the efficacy and safety of rechallenge chemotherapy in the third or later-line treatment in patients with advance...
Detailed Description
The treatment for reintroduction was oxaliplatin- or irinotecan-based chemo-regimen. Optional chemotherapy regimen included XELOX,FOLFOX,FOLFIRI,Irinotecan single-agent
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients age between 18 and 80 years
- Histologically confirmed metastatic colorectal cancer (mCRC)
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Treatment failure to at least two lines of chemotherapy (regimens should include oxaliplatin, fluorouracil and irinotecan); progression free survival (PFS) of prior oxaliplatin or irinotecan-based chemotherapy should be at least four months without any unrecoverable toxicity. Prior target therapy was acceptable
- For those who received other anti-tumor treatment, the toxicity should have been restored, with the time interval from last dose of cytotoxic drugs, radiation or surgery (the wound should be healed completely) ≥3 weeks
- Life expectancy≥12 weeks
- At least one measurable lesion as defined by RECIST 1.1
- Acceptable hematologic, hepatic, and renal function within 7 days from screening: the blood ANC count≥1.5\*10\^9/L; hemoglobin≥9.0 g/dl, the blood platelet count≥80 x 10\^9/L, total bilirubin\<1.5\*upper limits of normal(ULN), ALT and AST\<2.5\*ULN(\< 5 \*ULN for patients with live metastasis), endogenous creatinine clearance rate\>50ml/min
- Targeted drugs are currently not suitable or affordable
- Exclusion Criteria
- Receiving other systemic anti-cancer treatment within 3 weeks
- Prior radiation therapy of target measurable lesion
- Presence of Grade III or IV chemo-related toxicity in previous treatment without recovery to Grade II or less
- With other malignant tumor in 5 years; except for cured cervical carcinoma in situ or basal cell carcinoma
- Symptomatic intracranial or meningeal metastasis
- History of uncontrolled seizures, central nervous system dysfunction or mental disorder
- Uncontrolled pleural or peritoneal effusion
- Severe life-threatening concomitant disease that might impair the safety of patients or affect the completion of treatment, according to the researcher's judgment
Exclusion
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03485027
Start Date
January 24 2018
End Date
July 1 2023
Last Update
December 8 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032