Intrahepatic Cholangiocarcinoma (Icc)Phase 3RAINBOWNCT07691515
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
A Phase 3 study testing Gemcitabine, Cisplatin and Tislelizumab in people with Intrahepatic Cholangiocarcinoma (Icc), run by Zhejiang Cancer Hospital at 18 sites in China.
Trial summary
This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- Gemcitabine, Cisplatin and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 18 sitesChina
- Study dates
- Jul 2026to Jul 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
- Age ≥18 years.
- Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.
- No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.
- At least one measurable intrahepatic lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Child-Pugh class A liver function.
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- Life expectancy ≥3 months.
- Adequate hematologic, hepatic, renal, and thyroid function within 14 days before study start, defined as:
- Absolute neutrophil count ≥1.5 × 10⁹/L;
- Platelet count ≥75 × 10⁹/L;
- Hemoglobin ≥90 g/L;
- Serum albumin ≥30 g/L;
- Total bilirubin ≤1.5 × upper limit of normal;
- AST and ALT <1.5 × upper limit of normal, and ALP <4 × upper limit of normal;
- TSH <1 × upper limit of normal, with T3 and T4 within the normal range;
- Serum creatinine <1.5 × upper limit of normal and creatinine clearance ≥60 mL/min.
Who cannot join
- Diffuse infiltrative liver lesions.
- Contraindications to TACE.
- Allergy to intravenous contrast agent.
- pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception.
- Patients with HIV or syphilis infection.
- Patients with concurrent malignancies or other malignancies within 5 years before enrollment.
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- History of allogeneic organ transplantation.
- Severe dysfunction of the heart, kidney, or other organs.
- Severe clinically active infection > grade 2 according to NCI-CTC v5.0.
- Psychiatric illness that may affect the informed consent process; Inability to take oral medications; Participation in another drug clinical trial within 12 months before enrollment.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Yudong Xiao, +86 136 3740 3027, xiaoyudong222@csu.edu.cn
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Qi Liang, +86 137 8731 8180, csuliangqi10@163.com
West China School of Medicine/West China Hospital, Sichuan University (WCSM/WCH, SCU)
Chengdu, Sichuan, 610041
Chang Liu, +86 18980606382, drliuchang@wchscu.cn
Ganzhou Hospital-Nanfang Hospital, Southern Medical University
Ganzhou, Jiangxi, 341000
Yusheng Song, +86 135 7675 2988, 646993126@qq.com
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Kuang, 020-87755766, kuangm@mail.sysu.edu.cn
Zhenwei Peng, pzhenw@mail.sysu.edu.cn
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510168
Liangliang Qiao, +86 13544539881, 271937316@qq.com
Guangdong Second People's Hospital
Guangzhou, Guangdong, 510317
Chengjiang Xiao, +86 13602808387, Xxx196610@163.com
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 511400
Fuxi Huang, +86 18902299938, Fuxihuang2006@126.com
The Second Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, 524003
Kangshun Zhu, +86 13602864242, Zhksh010@163.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Gaojun Teng, +86 0571 - 88122222, gjteng@seu.edu.cn
Binyan Zhong, +86 15850522044, byzhongir@sina.com
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030
Yuchuang Liang, +86 13322888181, jmlyc@21cn.com
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000
Xiaogang Hu, +86 135 8866 8173, heartdoctor@163.com
Lishui Central Hospital
Lishui, Zhejiang, 323020
Jiansong Ji, +86 0578-2285888, jjstcty@sina.com
Jianfei Tu, jianfei1133@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
Junhua Ai, +86 18170936163, aijh0001@163.com
NingBo No.2 Hospital
Ningbo, Zhejiang, 315010
Yunjie Chen, +86 13857877137, a88960317@163.com
NingBo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315048
Shengdong Wu, +86 13567886669, 13567886669@139.com
The Affiliated Hospital of QingDao University
Qingdao, Shandong, 266000
Song Wang, +86 18661805592, derekqyfy@126.com
Wuhan Union Hospital of China
Wuhan, Hubei, 430022
Xuefeng Kan, +86 13545874189, xkliulang1314@163.com
About this study
Official title: Transcatheter Arterial Chemoembolization in Combination With Tislelizumab Plus Lenvatinib Versus Systemic Cisplatin Plus Gemcitabine in Combination With Tislelizumab for Unresectable Intrahepatic Cholangiocarcinoma: A Phase III, Multicenter, Randomized Controlled Trial
This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma.
Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc)
- Being tested
- Gemcitabine, Cisplatin, Tislelizumab, Lenvatinib, Transcatheter Arterial Chemoembolization
- Keywords
- Intrahepatic Cholangiocarcinoma, randomized controlled trial, Transcatheter Arterial Chemoembolization, Tislelizumab, Lenvatinib, GemCis
- 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.
GemcitabineDrug
Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, up to 8 cycles.
CisplatinDrug
Cisplatin 25 mg/m² intravenously on Day 1 and Day 8 of each 21-day cycle, up to 8 cycles.
TislelizumabDrug
Tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle, followed by maintenance tislelizumab every 3 weeks.
LenvatinibDrug
Oral lenvatinib once daily, 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight <60 kg, with dose modification according to toxicity.
Transcatheter Arterial ChemoembolizationProcedure or surgery
Conventional TACE or drug-eluting bead TACE are allowed. TACE may be repeated based on imaging assessment every 6 weeks ±7 days and investigator judgment.
Hepatic Arterial Infusion ChemotherapyProcedure or surgery
Optional hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to protocol-defined dose ranges.
| Study group | Role | What they receive |
|---|---|---|
| TACE Plus Tislelizumab and Lenvatinib | Experimental | Participants will receive tislelizumab 200 mg intravenously every 3 weeks and oral lenvatinib once daily at a starting dose of 12 mg for body weight ≥60 kg or 8 mg for body weight <60 kg. TACE will be performed after initiation of lenvatinib and may be repeated based on radiologic response, residual viable tumor, liver function, and investigator assessment. Both conventional TACE (cTACE) and drug-eluting beads TACE are allowed, and hepatic artery infusion chemotherapy may be added at investigator's discretion. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria. Receives: Drug: Tislelizumab; Drug: Lenvatinib; Procedure: Transcatheter Arterial Chemoembolization; Procedure: Hepatic Arterial Infusion Chemotherapy |
| Gemcitabine-Cisplatin Plus Tislelizumab | Active comparator | Participants will receive cisplatin 25 mg/m² on Day 1 and Day 8, gemcitabine 1000 mg/m² on Days 1 and 8, and tislelizumab 200 mg on Day 1 of each 3-week cycle for up to 8 cycles. After completion of gemcitabine-cisplatin treatment, participants will continue tislelizumab 200 mg intravenously every 3 weeks. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria. Receives: Drug: Gemcitabine; Drug: Cisplatin; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from enrollment/randomization to death from any cause. Participants who withdraw are lost to follow-up or remain alive at the end of the study will be censored at the date they were last known to be alive.
Measured: From randomization to death from any cause, assessed up to approximately 48 months
Secondary outcomes (7)
Progression-Free Survival
Defined as the time from randomization to disease progression or death from any cause. Participants without progression or death will be censored at the last date known to be progression-free.
Measured: From randomization to disease progression or death, assessed up to approximately 48 months
Time to Progression
Defined as the time from randomization to disease progression. Participants who die without prior progression, withdraw, are lost to follow-up, or remain progression-free at study end will be censored at the last date known to be progression-free.
Measured: From randomization to disease progression, assessed up to approximately 48 months
Objective Response Rate
Defined as the proportion of participants achieving complete response or partial response according to RECIST v1.1.
Measured: Assessed every 6 weeks ±7 days, up to approximately 48 months
Disease Control Rate
Defined as the proportion of participants achieving complete response, partial response, or stable disease according to RECIST v1.1.
Measured: Assessed every 6 weeks ±7 days, up to approximately 48 months
Incidence of Grade ≥3 Adverse Events
Defined as the occurrence of grade 3 or higher hematologic or non-hematologic toxicities, graded according to CTCAE v5.0.
Measured: From first dose of study treatment through 28 days after the last dose of study treatment
Quality of Life Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 is a 30-item questionnaire used to assess health-related quality of life in patients with cancer. Scores are linearly transformed to a 0 to 100 scale. For the global health status/quality-of-life scale and functional scales, higher scores indicate better health-related quality of life or functioning. For symptom scales and single symptom items, higher scores indicate a higher symptom burden or worse symptoms.
Measured: Baseline and during treatment/follow-up, assessed up to approximately 48 months
Quality of Life Assessed by the EuroQol Five-Dimension (EQ-5D)
The EuroQol Five-Dimension Three-Level Questionnaire is a standardized instrument for measuring health-related quality of life. The descriptive system includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored from 1 to 3, where 1 indicates no problems, 2 indicates some or moderate problems, and 3 indicates extreme problems or inability to perform the activity. Higher scores in each dimension indicate more severe problems or worse health status.
Measured: Baseline and during treatment/follow-up, assessed up to approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJul 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-Jun Teng, Zhejiang Cancer Hospital
- Investigators
- Gaojun Teng, MD, Principal investigator, Zhejiang Cancer HospitalMin Kuang, MD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityJiansong Ji, MD, Principal investigator, The Central Hospital of Lishui City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691515
- Sponsor's protocol ID
- RAINBOW 01
- Acronym
- RAINBOW
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy, ethical, and regulatory considerations.