Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms

NCT06767813 | Recruiting Phase 2

• 1 other identifier: TQB2868-ALTN-II-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

Brief Summary

To evaluate the efficacy and safety of TQB2868 injection combined with anlotinib capsule and chemotherapy in treated patients with Pancreatic Neoplasms

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  The time between the start of treatment and tumorigenesis (in any aspect) progression or death (due to any cause). The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days).

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

Secondary Outcomes (12)

• Objective Response Rate (ORR)

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

• Overall survival (OS)

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

• Duration of Response (DOR)

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

• Disease Control Rate (DCR)

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

• Incidence and severity of adverse events (AEs)

  The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)

Study Arms (2)

TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules

EXPERIMENTAL

Treatment period: TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle. Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase. Maintenance period: TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle. Oral administration of Anlotinib capsules tablets once a day, for 2 weeks followed by a 1 week untreated recovery phase.

Drug: TQB2868 injection; Drug: Gemcitabine injection; Drug: Albumin paclitaxel injection; Drug: Anlotinib capsules

TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection

EXPERIMENTAL

Treatment period TQB2868 injection combined with Gemcitabine injection and Albumin paclitaxel injection, 28 days as a treatment cycle. Maintenance period TQB2868 injection combined with Gemcitabine injection, 21 days as a treatment cycle.

Drug: TQB2868 injection; Drug: Gemcitabine injection; Drug: Albumin paclitaxel injection

Interventions

TQB2868 injection DRUG

TQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein.

TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection; TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules

Gemcitabine injection DRUG

Gemcitabine injection

TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection; TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules

Albumin paclitaxel injection DRUG

Albumin paclitaxel injection

TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection; TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules

Anlotinib capsules DRUG

Anlotinib capsules

TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must voluntarily participate in the study and sign the informed consent form.
• Aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.
• Diagnosed with pancreatic ductal adenocarcinoma through histological or cytological confirmation.
• Have at least one evaluable metastatic lesion according to RECIST 1.1 criteria;
• No prior systemic anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy). Patients who experience disease progression more than 6 months after completing neoadjuvant or adjuvant therapy are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of more than 3 months.
• Normal major organ function.
• Patients must use reliable contraception during the study period and for 6 months after the end of the study period; Female participants must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

You may not qualify if:

• Subjects with a history of or concurrent diagnosis of other malignant tumors within the past 5 years.
• Unresolved toxicities from prior treatments exceeding Grade 1 according to Common Terminology Criteria (CTC) AE criteria, excluding alopecia.
• Major surgical procedures, significant traumatic injuries, or unhealed wounds or fractures within 28 days prior to the first dose.
• Any bleeding or hemorrhagic event of ≥ Grade 3 according to CTC AE criteria within 4 weeks prior to the first dose.
• Arterial or venous thrombotic events within 6 months prior to the first dose.
• Active gastric or duodenal ulcers, perforations, persistent positive fecal occult blood tests, ulcerative colitis, or other gastrointestinal bleeding conditions within 6 months prior to the first dose; or other bleeding conditions as assessed by the investigator.
• Hepatitis B virus (HBV)-infected patients unable to adhere to consistent antiviral therapy, or Hepatitis C virus (HCV)-infected patients (positive for HCV Ab or HCV RNA) deemed unstable by the investigator or requiring continued antiviral therapy without consistent adherence.
• History of substance abuse involving psychotropic drugs that cannot be discontinued or presence of psychiatric disorders.
• Symptomatic interstitial lung disease or conditions likely to cause drug-induced lung toxicity or related pneumonitis.
• Presence of any severe and/or uncontrolled diseases.
• Histological or cytological confirmation of other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, or pancreatoblastoma.
• Tumors confirmed via imaging (CT or MRI) to have invaded major blood vessels, with the investigator deeming a high likelihood of fatal hemorrhage during the study.
• Tumors confirmed via imaging (CT or MRI) to have invaded the gastrointestinal tract, with a high risk of bleeding based on endoscopy and investigator assessment.
• Known central nervous system metastases and/or carcinomatous meningitis.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, as assessed by the investigator.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.: lead

Study Sites (7)

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450039, China

NOT YET RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; anlotinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Xianjun Yu, Doctor

CONTACT

021-64175590; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: March 19, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-08

Locations

CN (7)