A Phase 2/3 interventional study of Albumin-bound Paclitaxel + Tegafur Gimeracil Oteracil (S-1) + Anlotinib and Oxaliplatin + Leucovorin + Fluorouracil (FOLFOX regimen) in Biliary Tract Cancer, Second Line Treatment and Chemotherapy, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Sun Yat-sen University · Phase 2/3, Interventional, and Treatment
Biliary tract cancer (BTC) presents with a 5-year survival rate less than 5%. The goal of this clinical trial is to evaluate if Anlotinib plus Nab-Paclitaxels and S-1 as second-line regimen can improve the treatment efficacy in advanced biliary tract cancer (BTC) after progression upon first-line standard treatment, in comparison with standard second-line FOLFOX regimen.
Biliary tract cancer (BTC) mainly includes intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma, and the 5-year survival rate is less than 5%. Most patients were diagnosed as advanced stage, and missed the opportunity of radical surgery. ABC-02 study established gemcitabine combined with platinum drugs as the first-line standard treatment for unresectable BTC. However, after the disease progresses, the second-line treatment options and efficacies are limited. In recent years, BTC second-line treatment has made some breakthroughs in the field of chemotherapy and targeted therapy. However, the benefits of chemotherapy, immunotherapy and targeted drugs alone in the second line treatment of BTC is unsatisfactory. The combined scheme of two or three drugs sees the possibility of patients benefiting, but it still needs better scheme design and larger sample size for further verification. A phase II single-arm small-sample clinical trial exploring albumin-bound paclitaxel combined with S-1 capsule in the first-line treatment of advanced biliary adenocarcinoma initially showed the efficacy and safety of AS regimen in cholangiocarcinoma, and the efficacy and safety of Anlotinib in BTC were also confirmed in the small-sample study. Therefore, this study intends to explore the efficacy and safety of the second-line treatment of advanced BTC with Anlotinib combined with AS chemotherapy in comparison with the establised standard second-line regimen (FOLFOX).
492 studies on the registry are indexed under Biliary Tract Neoplasms; 191 are open to participants now.
This study's planned enrollment of 206 is above the median of 57 across 409 interventional studies indexed under Biliary Tract Neoplasms.
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Exclusion Criteria:
Experimental treatment under study
Drug: Albumin-bound Paclitaxel + Tegafur Gimeracil Oteracil (S-1) + Anlotinib
Standard of care second-line treatment for advanced biliary tract cancer
Drug: Oxaliplatin + Leucovorin + Fluorouracil (FOLFOX regimen)
Drug pages: Albumin-Bound Paclitaxel · Tegafur-gimeracil-oteracil · Anlotinib
Albumin-bound Paclitaxel, 125mg/m2,iv.drip,d1,d8,Q3W +Tegafur Gimeracil Oteracil (S-1) 40-60mg,p.o,bid,d1-d14,Q3W+Anlotinib 10mg,p.o,d1-d14,Q3W
Drug page: Folfox protocol
Oxaliplatin 85 mg/m2,d1,iv.drip,Q2W + Leucovorin 400mg/m2,d1,iv.drip,Q2W+ Fluorouracil 2400 mg/m2 civ46h, Q2W
Overall Survival
Overall Survival (OS), defined as the time between the date of the subject's first dose and the subject's death from all causes. The OS of subjects who were alive at the time of the final follow-up visit was counted as data censored at the time of the final follow-up visit.
Time frame: From randomisation to death, up to 5 years
Progression-Free Survival
Progression-Free Survival (PFS) is defined as the time from the date of the subject's first dose of medication to the date of the first documented tumor progression (assessed according toRECIST 1.1 criteria, with or without continuation of treatment) or the date of death from anycause, whichever occurs first. The median PFS and its 95% Cl will be analyzed using the Kaplan-Meier method and survival graphs will be plotted.
Time frame: From randomisation to disease progression or death, up to 5 years
Objective Response Rate
Refers to the proportion of patients whose tumors shrank by a certain amount and remained sofor a certain period of time, and includes both CR and PR cases. Objective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria).
Time frame: From randomisation, up to 5 years
Disease control rate
Refers to the proportion of patients whose tumors shrank by a certain amount and remained sofor a certain period of time, and includes both CR and PR cases. Obiective tumor remission was assessed using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criterial
Time frame: From randomisation, up to 5 years
Quality of Life
Patients' quality of life was assessed according to the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), assessed at baseline and every 3 weeks thereafter
Time frame: From baseline, every 3weeks until end of treatment, an average of 4-6 months
Adverse Events
Defined as the proportion of grade ≥3 hematologic or non-hematologic toxic events occurring from the start of medication to the end of follow-up. Adverse events include, but are not limited to, liver dysfunction, hematologic system damage, pulmonary toxicity, and ocular toxicity. The severity of adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Time frame: From randomisation, up to 5 years
Plan to share: No
Start is estimated for Nov 2024; primary completion for Sep 2029, 57 months later.
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Studies of the drugs tested here: Albumin-Bound Paclitaxel · Tegafur-gimeracil-oteracil · Anlotinib