New pill takes on bile duct cancer: phase 3 trial launches

NCT ID NCT07328919

Not yet recruiting Disease control Sponsor: TransThera Sciences (Nanjing), Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests a new daily pill, TT-00420, against standard chemotherapy in 138 adults with advanced bile duct cancer that has a specific genetic change (FGFR2 fusion or mutation) and has worsened after first treatment. The study compares how long the cancer stays under control and overall survival. It is open-label, meaning everyone knows which treatment they receive.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: TT-00420 (tinengotinib) tablets
What this could lead to: If successful, this could provide a new targeted treatment option for people with a specific type of advanced bile duct cancer that has stopped responding to initial chemotherapy.
What could go wrong: This is an early-stage Phase 3 trial with only 138 participants, so results may not apply to all patients. The drug may not prove more effective than chemotherapy and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension intrahepatic cholangiocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ADVANCED CHOLANGIOCARCINOMA INTRAHEPATIC CHOLANGIOCARCINOMA (ICC)

Contacts and locations

Locations

Anhui Provincial Hospital

Hefei, Anhui, China
Beijing Cancer Hospital

Beijing, China
Beijing Tsinghua Changgung Hospital

Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China
Eastern Hepatobiliary Surgery Hospital

Shanghai, China
Fudan University Shanghai Cancer Hospital

Shanghai, China
Fujian Cancer Hospital

Fuzhou, Fujian, China
Hunan Cancer Hospital

Changsha, Hunan, China
Jinan Central Hospital

Jinan, Shandong, China
Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China
Peking Union Medical College Hospital

Beijing, China
Shandong Cancer Hospital

Jinan, Shandong, China
Sichuan Cancer Hospital

Chengdu, Sichuan, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
West China Hospital of Sichuan University

Chengdu, Sichuan, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China
Zhongnan hospital of Wuhan University

Wuhan, Hubei, China
Zhongshan Hospital, Fudan University

Shanghai, China
Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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