Intrahepatic Cholangiocarcinoma (Icc)Phase 3NCT07328919

Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations

A Phase 3 study testing TT-00420 (tinengotinib) and Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine in people with Intrahepatic Cholangiocarcinoma (Icc) and Advanced Cholangiocarcinoma, run by TransThera Sciences (Nanjing), Inc. at 20 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma
What is being tested?: TT-00420 (tinengotinib) and Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 138 participants
Where: 20 sitesChina
Study dates: Jan 2026to 31 Dec 2030
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 18 years of age at the time of signing the informed consent form (ICF).
Histologically or cytologically confirmed intrahepatic cholangiocarcinoma.
Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection.
Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1/PD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine/capecitabine with or without a platinum-based agent.
Note: Recurrence within 6 months after completion of adjuvant or neoadjuvant therapy will be considered as a line of systemic therapy. Local treatments do not count as systemic therapy.
The presence of FGFR2 gene fusion/rearrangement or mutation must be confirmed by detection using tumor tissue samples provided by the patient and analyzed by a central laboratory.

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At least one radiographically measurable lesion must be present according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
ECOG ≤ 1.
Subjects must have adequate organ and bone marrow function.

Who cannot join

Subjects with a history of prior treatment with TT-00420 tablets.
Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available.
Subjects receiving corticosteroid therapy for CNS metastases are also ineligible.
Concurrent active malignancy requiring active treatment. Malignancies diagnosed >5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed.
Administration of other anti-tumor drugs prior to randomization with an interval of ≤ 5 half-lives or 14 days (whichever is shorter), or failure to recover from adverse events of prior therapies (except for adverse events of ≤ Grade 1, or ≤ Grade 2 events judged by the investigator as not constituting a safety risk).
Prior radiation therapy (large-field radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, before randomization), or failure to recover from related adverse events, is excluded. However, initiation of the investigational drug during the washout period is permitted with sponsor approval, if the investigator believes it is in the subject's best interest based on a favorable benefit-risk assessment.
Subjects who have undergone major surgery within 4 weeks prior to randomization, or who have not recovered from related adverse events (with the exception of ≤ Grade 1 events or non-risk Grade 2 events per investigator's judgment), are excluded.
Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and/or ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Caixia Sun contact

025-58216298

sun_caixia@transtherabio.com

City, postcode or hospital

20 sites in 1 country

China20 sites

Beijing Cancer Hospital
Beijing
Lin Shen, MD
Beijing Tsinghua Changgung Hospital
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Peking Union Medical College Hospital
Beijing
Hunan Cancer Hospital
Changsha, Hunan
Sichuan Cancer Hospital
Chengdu, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan
Fujian Cancer Hospital
Fuzhou, Fujian
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Anhui Provincial Hospital
Hefei, Anhui
Jinan Central Hospital
Jinan, Shandong
Shandong Cancer Hospital
Jinan, Shandong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Eastern Hepatobiliary Surgery Hospital
Shanghai
Fudan University Shanghai Cancer Hospital
Shanghai
Zhongshan Hospital, Fudan University
Shanghai
Zhongnan hospital of Wuhan University
Wuhan, Hubei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy

Read the detailed description

Approximately 138 subjects will be enrolled. Eligible subjects will be randomized in a 2:1 ratio to one of the two arms: Arm A (TT-00420 tablet monotherapy) or Arm B (chemotherapy).

Conditions: Intrahepatic Cholangiocarcinoma (Icc), Advanced Cholangiocarcinoma
Being tested: TT-00420 (tinengotinib), Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine
Medical subject headings: Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TT-00420 (tinengotinib)Drug
Subject will receive TT-00420 (tinengotinib) once daily in 28-day cycles with initial dosage of 10 mg QD per protocol defined schedule.
Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabineDrug
Subjects will receive chemotherapy (mFOLFOX regimen, XELIRI regimen, or irinotecan monotherapy). The dosing schedule involves intravenous administration or oral intake every two weeks (except for capecitabine). Treatment continues until the occurrence of confirmed disease progression, intolerable toxicities, withdrawal of informed consent, death, or other reasons specified in the protocol (whichever occurs first). Among these, subjects receiving the mFOLFOX regimen are limited to a maximum of 6 treatment cycles (approximately 12 administrations).

Study groups in NCT07328919
Study group	Role	What they receive
Arm A (TT-00420 monotherapy)	Experimental	The starting dose of TT-00420 tablets is 10 mg QD (5 mg per tablet, 2 tablets), administered orally and taken continuously. Receives: Drug: TT-00420 (tinengotinib)
Arm B (chemotherapy)	Active comparator	Chemotherapy includes mFOLFOX regimen, XELIRI regimen or irinotecan monotherapy. Receives: Drug: Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

PFS by BICR
Progression-free survival (PFS) by BICR: PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or date of death due to any cause, whichever is earlier.
Measured: From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months.

Secondary outcomes (6)

Overall Survival (OS)
OS is defined as the time from date of randomization to date of death of any cause.
Measured: From first study drug administration until the date of death from any cause, assessed up to 24 months.
PFS by Investigators per RECIST v1.1.
PFS is defined as the time from date of randomization to the date of first documented disease progression as assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: From first study drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Objective Response Rate (ORR) by BICR and by Investigator
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Duration of Response (DOR) by BICR and by Investigator
Duration of response for CR or PR based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Disease Control Rate (DCR)
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) or a stable disease (SD) based on RECIST version 1.1.
Measured: Through study completion, an average of 9 months.
Incidence, duration, and severity of adverse events (AEs)
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Measured: Up to 30 days from study discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 202631 Dec 2030

First posted9 Jan 2026
Study startJan 2026 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intrahepatic Cholangiocarcinoma (Icc)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 138 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07328919
Sponsor's protocol ID: TT00420CN18
Status last verified: Dec 2025
First submitted: 26 Dec 2025
Last updated: 9 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No