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

Multi-cohort, Open, Phase II Clinical Study of TQB2868 Injection Combined With Arotinib Capsule and Chemotherapy in the First-line Treatment of Pancreatic Neoplasms

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Drug: TQB2868 injection; Drug: Gemcitabine injection; Drug: Albumin paclitaxel injection; Drug: Anlotinib capsules

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xianjun Yu, Doctor; Phone Number: 021-64175590; Email: yuxianjun@fudanpci.org

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Xiaobing Chen, Doctor; Phone Number: 13937100233; Email: 2290773710@qq.com
    • Zhengzhou, Henan, China, 450039
      • Not yet recruiting
      • The Second Affiliated Hospital of Zhengzhou University
      • Contact: Jian Wang, Doctor; Phone Number: 13663000871; Email: wj68happy@hotmail.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Not yet recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Juan Du, Doctor; Phone Number: 13951826526; Email: dujuanglyy@163.com
    • Nanjing, Jiangsu, China, 210000
      • Not yet recruiting
      • Jiangsu Provincial People's Hospital
      • Contact: Kuirong Jiang, Doctor; Phone Number: 15312995688; Email: jiangkuirong@163.com
    • Suzhou, Jiangsu, China, 215006
      • Not yet recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Wei Li, Doctor; Phone Number: 15895401045; Email: liwei10@suda.edu.cn
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xianjun Yu, Doctor; Phone Number: 021-64175590; Email: yuxianjun@fudanpci.org
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Not yet recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Gang Chen, Doctor; Phone Number: 13616619566; Email: cg_2188@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History of severe allergic reactions to biologic agents or known hypersensitivity to any component of TQB2868 injection.
• Chronic treatment with systemic corticosteroids or other immunosuppressive agents within 28 days prior to the first dose, and continued use of such medications within 2 weeks after the first dose.
• Receipt of live attenuated vaccines within 28 days prior to the first dose or planned administration of live attenuated vaccines during the study.
• Systemic therapy required within 2 years prior to the first dose for any condition. Alternative therapies are not considered systemic therapy.
• Participation in other clinical trials involving anti-tumor drugs within 28 days prior to the first dose.
• Any comorbidities or conditions deemed by the investigator to pose severe risks to the subject's safety or the completion of the study, or any other reasons rendering the subject unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2868 injection+Gemcitabine injection+ Albumin paclitaxel injection+ Anlotinib capsules; 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; TQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein.; Drug: Gemcitabine injection; Gemcitabine injection; Drug: Albumin paclitaxel injection; Albumin paclitaxel injection; Drug: Anlotinib capsules; Anlotinib capsules
Experimental: TQB2868 injection+Gemcitabine injection +Albumin paclitaxel injection; 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; TQB2868 injection is an anti-PD 1/growth factor (GF)-β Receptor Type II (TGF-βRII) bifunctional fusion protein.; Drug: Gemcitabine injection; Gemcitabine injection; Drug: Albumin paclitaxel injection; Albumin paclitaxel injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit is the sum of the proportion of complete and partial responses.	The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Overall survival (OS)	Time from the start of treatment to 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)
Duration of Response (DOR)	The period between the first diagnosis of CR or PR and the discovery of progressive disease (PD).	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 percentage of cases with remission (PR+CR) and stable lesion (SD) after treatment accounted for the number of evaluable cases.	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 occurrence of all adverse events.	The evaluation was based on the date of first dose, and efficacy was evaluated every 8 weeks (56±7 days)
Peak concentration (Cmax)	Maximum plasma drug concentration.	Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Transforming growth factor-beta (TGF-β)	The relationship between TGF - β content in plasma and anti-tumor efficacy.	Before first dose, 30 minutes after the first dose, pre-dose at Cycle 2 Day 1, pre-dose at the first efficacy assessment, pre-dose at the time of remission at the first efficacy evaluation, and at the time of progression, each cycle is 28 days.
Incidence of immunogenicity (ADA)	Incidence of immunogenicity (ADA).	Cycle1, 2, 4, 8: Before injection. 30 and 90 days after the last dose
Time to maximum blood concentration (Tmax)	Time to maximum blood concentration.	Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Area under the time-concentration curve (AUC0-t）	Area under the time-concentration curve, 0-t hours after administration.	Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
The area under the time-concentration curve ranges from 0 to infinity after administration (AUC0-∞)	The area under the time-concentration curve ranges from 0 to infinity after administration (AUC0-∞).	Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.
Plasma drug half-life (T1/2)	Plasma drug half-life	Day1-7 of cycle1 and cycle 4 : 0 hour pre-dose, 0,1, 2, 4, 8, 24, 48, 72, 144 hours after dose. Cycle1 Day15: 0 hour pre-dose. Day1 of cycle2 and 3 : 0 hour pre-dose. 0 hour after dose, Cycle4 Day15: 0 hour pre-dose. 28days as a cycle.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; anlotinib
• Other Study ID Numbers: TQB2868-ALTN-II-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No