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The study of safety and efficacy of combination of anlotinib and sintilimab for patients with metastatic or recurrent gallbladder cancer

The study of safety and efficacy of combination of anlotinib and sintilimab for patients with metastatic or recurrent gallbladder cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039606
Enrollment
Unknown
Registered
2020-11-03
Start date
2020-11-16
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gallbladder cancer

Interventions

test group:anlotinib and sintilimab

Sponsors

Dongfang Hepatobiliary Surgery Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18 or above; 2. Subjects with ECoG score of 0-2; 3. Patients with gallbladder carcinoma confirmed by histology or cytology, including adenocarcinoma, squamous carcinoma and squamous adenocarcinoma; 4. Advanced patients who have received S-1 or gemcitabine based chemotherapy in the past; 5. According to RECIST 1.1, the patient has at least one measurable lesion; 6. Patients with an estimated survival time of more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Patients with known or history of central nervous system metastasis before screening; 2. The imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was highly likely to invade the important blood vessels during the treatment, causing fatal massive hemorrhage; 3. Patients who have received immunotherapy or targeted therapy in the past; 4. Patients with immune diseases or other contraindications to immunotherapy.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
PFS;OS;DCR;DOR;AE;

Countries

China

Contacts

Public ContactXiaoqing Jiang

Dongfang Hepatobiliary Surgery Hospital of Naval Medical University

13916309500@126.com+86 21-81875282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026